Trial Outcomes & Findings for Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face (NCT NCT02632110)

Results Overview

Number of AK Fields with 0 lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

Week 12

Results posted on

2018-01-18

Participant Flow

Unit of analysis: AK Fields

Participant milestones

Participant milestones
Measure	MN + ALA 25 Min 10 mW Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application	ALA 25 Min 10 mW Aminolevulinic acid photodynamic therapy (ALA-PDT), 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle (MN): one actinic keratosis (AK) Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. Investigational Blue Light (IBL) 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 25 Min 20 mW Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + VEH 60 Min 10 mW Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application	VEH 60 Min 10 mW Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Overall Study STARTED	25 25	25 25	27 27	27 27	29 29	29 29	26 26	26 26	30 30	30 30
Overall Study COMPLETED	24 24	24 24	27 27	27 27	28 28	28 28	23 23	23 23	29 29	29 29
Overall Study NOT COMPLETED	1 1	1 1	0 0	0 0	1 1	1 1	3 3	3 3	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	MN + ALA 25 Min 10 mW Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application	ALA 25 Min 10 mW Aminolevulinic acid photodynamic therapy (ALA-PDT), 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle (MN): one actinic keratosis (AK) Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. Investigational Blue Light (IBL) 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 25 Min 20 mW Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + VEH 60 Min 10 mW Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application	VEH 60 Min 10 mW Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Overall Study Withdrawal by Subject	1	1	0	0	1	1	3	3	1	1

Baseline Characteristics

Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALA 25 Min 10 mW n=25 Participants ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 25 Min 20 mW n=27 Participants ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 10 mW n=29 Participants ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 60 Min 20 mW n=26 Participants ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	VEH 60 Min 10 mW n=30 Participants Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	Total n=137 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 10 • n=5 Participants	64 years STANDARD_DEVIATION 8 • n=7 Participants	67 years STANDARD_DEVIATION 8 • n=5 Participants	66 years STANDARD_DEVIATION 9 • n=4 Participants	64 years STANDARD_DEVIATION 10 • n=21 Participants	65 years STANDARD_DEVIATION 9 • n=10 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	29 Participants n=10 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	20 Participants n=4 Participants	27 Participants n=21 Participants	108 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	26 Participants n=4 Participants	30 Participants n=21 Participants	136 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	27 Participants n=7 Participants	29 Participants n=5 Participants	26 Participants n=4 Participants	30 Participants n=21 Participants	137 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Skin Type Type I - Burns easily, never tans	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=10 Participants
Skin Type Type II - Burns easily, tans minimally	10 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants	14 Participants n=4 Participants	21 Participants n=21 Participants	76 Participants n=10 Participants
Skin Type Type III - Burns moderately, tans gradually	12 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	48 Participants n=10 Participants
Skin Type Type IV - Burns minimally, tans well	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Split-face study

Number of AK Fields with 0 lesions

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=23 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=23 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Complete Clearance Rate	10 AK Fields	12 AK Fields	19 AK Fields	15 AK Fields	18 AK Fields	18 AK Fields	16 AK Fields	15 AK Fields	4 AK Fields	4 AK Fields

SECONDARY outcome

Timeframe: Week 8

Population: split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.

Number of AK Fields with 0 Lesions

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Complete Clearance Rate	7 AK Fields	7 AK Fields	13 AK Fields	11 AK Fields	8 AK Fields	9 AK Fields	5 AK Fields	7 AK Fields	4 AK Fields	2 AK Fields

SECONDARY outcome

Timeframe: Week 12

Population: split-face.

Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Subject Satisfaction Score Excellent (very satisfied)	21 AK Fields	21 AK Fields	18 AK Fields	18 AK Fields	15 AK Fields	14 AK Fields	15 AK Fields	13 AK Fields	8 AK Fields	8 AK Fields
Subject Satisfaction Score Good (moderately satisfied)	5 AK Fields	5 AK Fields	10 AK Fields	9 AK Fields	7 AK Fields	8 AK Fields	8 AK Fields	10 AK Fields	3 AK Fields	3 AK Fields
Subject Satisfaction Score Fair (slightly satisfied)	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	4 AK Fields	4 AK Fields	1 AK Fields	1 AK Fields	7 AK Fields	7 AK Fields
Subject Satisfaction Score Poor (not satisfied)	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	12 AK Fields	12 AK Fields

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.

AK clearance rate (AKCR) for only those lesions present at Baseline

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Baseline AKCR	75.0 percentage cleared Standard Deviation 27.03	69.6 percentage cleared Standard Deviation 31.4	85.4 percentage cleared Standard Deviation 22.26	83.4 percentage cleared Standard Deviation 22.63	86.1 percentage cleared Standard Deviation 15.59	80.6 percentage cleared Standard Deviation 22.61	74.5 percentage cleared Standard Deviation 24.14	72.3 percentage cleared Standard Deviation 30.15	40.6 percentage cleared Standard Deviation 35.66	34.4 percentage cleared Standard Deviation 36.66

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: split-face

AK clearance rate for only those lesions present at Baseline

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=23 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=23 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Baseline AKCR	82.3 percentage cleared Standard Deviation 22.32	86.7 percentage cleared Standard Deviation 16.44	93.2 percentage cleared Standard Deviation 13.04	95.1 percentage cleared Standard Deviation 10.4	96.3 percentage cleared Standard Deviation 7.49	94.8 percentage cleared Standard Deviation 13.34	92.2 percentage cleared Standard Deviation 16.28	89.2 percentage cleared Standard Deviation 19.96	40.9 percentage cleared Standard Deviation 37.24	43.1 percentage cleared Standard Deviation 40.42

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.

Percent change in the total AK number as compared with Baseline

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Percent Change	-64.7 percent change Standard Deviation 32.32	-63.4 percent change Standard Deviation 36.04	-72.9 percent change Standard Deviation 29.58	-69.6 percent change Standard Deviation 34.46	-79.4 percent change Standard Deviation 17.3	-74.2 percent change Standard Deviation 28.56	-65.9 percent change Standard Deviation 28.4	-68.6 percent change Standard Deviation 30.99	-27.9 percent change Standard Deviation 47.29	-13.8 percent change Standard Deviation 49.02

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: split-face

Percent change in the total AK number as compared with Baseline

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=23 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=23 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Percent Change	-75.0 percent change Standard Deviation 32.35	-80.0 percent change Standard Deviation 25.1	-88.9 percent change Standard Deviation 21.36	-87.4 percent change Standard Deviation 17.47	-95.5 percent change Standard Deviation 10.16	-92.6 percent change Standard Deviation 19.08	-87.0 percent change Standard Deviation 22.52	-87.3 percent change Standard Deviation 20.45	-26.0 percent change Standard Deviation 50.29	-18.5 percent change Standard Deviation 54.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: split-face

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hyperpigmentation Grade 0	16 AK Fields	16 AK Fields	16 AK Fields	16 AK Fields	13 AK Fields	13 AK Fields	12 AK Fields	12 AK Fields	15 AK Fields	15 AK Fields
Hyperpigmentation Grade 1	6 AK Fields	6 AK Fields	11 AK Fields	9 AK Fields	8 AK Fields	8 AK Fields	10 AK Fields	11 AK Fields	12 AK Fields	13 AK Fields
Hyperpigmentation Grade 2	5 AK Fields	5 AK Fields	1 AK Fields	3 AK Fields	3 AK Fields	3 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields
Hyperpigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields
Hyperpigmentation Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hyperpigmentation Grade 2	6 AK Fields	5 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields
Hyperpigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields
Hyperpigmentation Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields
Hyperpigmentation Grade 0	15 AK Fields	15 AK Fields	14 AK Fields	15 AK Fields	10 AK Fields	10 AK Fields	12 AK Fields	12 AK Fields	15 AK Fields	15 AK Fields
Hyperpigmentation Grade 1	6 AK Fields	7 AK Fields	11 AK Fields	10 AK Fields	11 AK Fields	11 AK Fields	11 AK Fields	11 AK Fields	12 AK Fields	13 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hyperpigmentation Grade 0	14 AK Fields	14 AK Fields	16 AK Fields	16 AK Fields	12 AK Fields	12 AK Fields	11 AK Fields	11 AK Fields	16 AK Fields	15 AK Fields
Hyperpigmentation Grade 1	8 AK Fields	8 AK Fields	9 AK Fields	9 AK Fields	8 AK Fields	8 AK Fields	12 AK Fields	12 AK Fields	11 AK Fields	13 AK Fields
Hyperpigmentation Grade 2	5 AK Fields	5 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	3 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	0 AK Fields
Hyperpigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields
Hyperpigmentation Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hyperpigmentation Grade 0	16 AK Fields	16 AK Fields	16 AK Fields	16 AK Fields	10 AK Fields	10 AK Fields	11 AK Fields	11 AK Fields	16 AK Fields	16 AK Fields
Hyperpigmentation Grade 1	6 AK Fields	6 AK Fields	7 AK Fields	8 AK Fields	9 AK Fields	9 AK Fields	11 AK Fields	11 AK Fields	10 AK Fields	10 AK Fields
Hyperpigmentation Grade 2	5 AK Fields	5 AK Fields	3 AK Fields	2 AK Fields	3 AK Fields	3 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields
Hyperpigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	2 AK Fields	2 AK Fields
Hyperpigmentation Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hyperpigmentation Grade 0	15 AK Fields	15 AK Fields	19 AK Fields	19 AK Fields	10 AK Fields	10 AK Fields	10 AK Fields	10 AK Fields	16 AK Fields	16 AK Fields
Hyperpigmentation Grade 1	7 AK Fields	7 AK Fields	8 AK Fields	8 AK Fields	10 AK Fields	9 AK Fields	12 AK Fields	12 AK Fields	10 AK Fields	11 AK Fields
Hyperpigmentation Grade 2	5 AK Fields	5 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	3 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields
Hyperpigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	2 AK Fields	2 AK Fields
Hyperpigmentation Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hypopigmentation Grade 0	20 AK Fields	21 AK Fields	23 AK Fields	24 AK Fields	20 AK Fields	20 AK Fields	16 AK Fields	18 AK Fields	25 AK Fields	26 AK Fields
Hypopigmentation Grade 1	7 AK Fields	6 AK Fields	5 AK Fields	4 AK Fields	5 AK Fields	5 AK Fields	8 AK Fields	6 AK Fields	5 AK Fields	4 AK Fields
Hypopigmentation Grade 2	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	01 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hypopigmentation Grade 0	20 AK Fields	21 AK Fields	22 AK Fields	23 AK Fields	18 AK Fields	18 AK Fields	17 AK Fields	18 AK Fields	26 AK Fields	27 AK Fields
Hypopigmentation Grade 1	7 AK Fields	6 AK Fields	5 AK Fields	4 AK Fields	5 AK Fields	5 AK Fields	7 AK Fields	6 AK Fields	4 AK Fields	3 AK Fields
Hypopigmentation Grade 2	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hypopigmentation Grade 0	21 AK Fields	22 AK Fields	21 AK Fields	23 AK Fields	16 AK Fields	16 AK Fields	15 AK Fields	17 AK Fields	25 AK Fields	26 AK Fields
Hypopigmentation Grade 1	6 AK Fields	5 AK Fields	7 AK Fields	4 AK Fields	8 AK Fields	8 AK Fields	9 AK Fields	7 AK Fields	5 AK Fields	4 AK Fields
Hypopigmentation Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hypopigmentation Grade 0	21 AK Fields	21 AK Fields	18 AK Fields	19 AK Fields	15 AK Fields	15 AK Fields	15 AK Fields	17 AK Fields	23 AK Fields	23 AK Fields
Hypopigmentation Grade 1	6 AK Fields	6 AK Fields	8 AK Fields	7 AK Fields	8 AK Fields	8 AK Fields	8 AK Fields	6 AK Fields	6 AK Fields	6 AK Fields
Hypopigmentation Grade 2	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Hypopigmentation Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 0	18 AK Fields	20 AK Fields	21 AK Fields	21 AK Fields	16 AK Fields	16 AK Fields	16 AK Fields	18 AK Fields	23 AK Fields	22 AK Fields
Hypopigmentation Grade 1	9 AK Fields	7 AK Fields	7 AK Fields	7 AK Fields	7 AK Fields	7 AK Fields	7 AK Fields	5 AK Fields	7 AK Fields	8 AK Fields
Hypopigmentation Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Hypopigmentation Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: split face

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 0	16 AK Fields	16 AK Fields	17 AK Fields	16 AK Fields	16 AK Fields	15 AK Fields	12 AK Fields	12 AK Fields	15 AK Fields	15 AK Fields
Erythema Grade 1	8 AK Fields	8 AK Fields	12 AK Fields	12 AK Fields	9 AK Fields	9 AK Fields	10 AK Fields	11 AK Fields	12 AK Fields	11 AK Fields
Erythema Grade 2	3 AK Fields	3 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	3 AK Fields	4 AK Fields
Erythema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes after PDT #1

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 3	11 AK Fields	8 AK Fields	12 AK Fields	10 AK Fields	9 AK Fields	5 AK Fields	4 AK Fields	3 AK Fields	1 AK Fields	1 AK Fields
Erythema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 0	3 AK Fields	3 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	3 AK Fields	4 AK Fields	12 AK Fields	12 AK Fields
Erythema Grade 1	9 AK Fields	9 AK Fields	2 AK Fields	4 AK Fields	6 AK Fields	8 AK Fields	3 AK Fields	5 AK Fields	7 AK Fields	9 AK Fields
Erythema Grade 2	4 AK Fields	7 AK Fields	12 AK Fields	12 AK Fields	9 AK Fields	10 AK Fields	15 AK Fields	13 AK Fields	10 AK Fields	8 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 0	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	11 AK Fields	12 AK Fields
Erythema Grade 1	1 AK Fields	2 AK Fields	2 AK Fields	3 AK Fields	0 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	9 AK Fields	10 AK Fields
Erythema Grade 2	9 AK Fields	14 AK Fields	6 AK Fields	9 AK Fields	10 AK Fields	10 AK Fields	11 AK Fields	14 AK Fields	10 AK Fields	8 AK Fields
Erythema Grade 3	13 AK Fields	8 AK Fields	17 AK Fields	12 AK Fields	12 AK Fields	9 AK Fields	14 AK Fields	10 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 4	3 AK Fields	2 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields	4 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 0	14 AK Fields	14 AK Fields	15 AK Fields	15 AK Fields	12 AK Fields	13 AK Fields	9 AK Fields	10 AK Fields	13 AK Fields	13 AK Fields
Erythema Grade 1	9 AK Fields	10 AK Fields	9 AK Fields	10 AK Fields	11 AK Fields	9 AK Fields	13 AK Fields	11 AK Fields	14 AK Fields	14 AK Fields
Erythema Grade 2	4 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields	2 AK Fields	3 AK Fields	3 AK Fields	3 AK Fields	3 AK Fields	3 AK Fields
Erythema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 0	16 AK Fields	18 AK Fields	18 AK Fields	17 AK Fields	16 AK Fields	15 AK Fields	12 AK Fields	12 AK Fields	14 AK Fields	14 AK Fields
Erythema Grade 1	9 AK Fields	7 AK Fields	7 AK Fields	8 AK Fields	7 AK Fields	9 AK Fields	10 AK Fields	10 AK Fields	10 AK Fields	10 AK Fields
Erythema Grade 2	2 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	0 AK Fields	2 AK Fields	2 AK Fields	5 AK Fields	5 AK Fields
Erythema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Erythema Grade 0	19 AK Fields	18 AK Fields	20 AK Fields	19 AK Fields	16 AK Fields	17 AK Fields	15 AK Fields	14 AK Fields	15 AK Fields	14 AK Fields
Erythema Grade 1	7 AK Fields	8 AK Fields	7 AK Fields	8 AK Fields	8 AK Fields	7 AK Fields	7 AK Fields	8 AK Fields	8 AK Fields	9 AK Fields
Erythema Grade 2	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	7 AK Fields	7 AK Fields
Erythema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Erythema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 0	27 AK Fields	27 AK Fields	29 AK Fields	29 AK Fields	26 AK Fields	26 AK Fields	25 AK Fields	25 AK Fields	30 AK Fields	30 AK Fields
Edema Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes after PDT #1

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 0	23 AK Fields	23 AK Fields	23 AK Fields	26 AK Fields	22 AK Fields	24 AK Fields	20 AK Fields	20 AK Fields	29 AK Fields	28 AK Fields
Edema Grade 1	2 AK Fields	3 AK Fields	5 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields	3 AK Fields	4 AK Fields	1 AK Fields	2 AK Fields
Edema Grade 2	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 3	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 1	3 AK Fields	3 AK Fields	5 AK Fields	9 AK Fields	9 AK Fields	5 AK Fields	8 AK Fields	4 AK Fields	0 AK Fields	1 AK Fields
Edema Grade 0	20 AK Fields	20 AK Fields	17 AK Fields	14 AK Fields	8 AK Fields	13 AK Fields	13 AK Fields	18 AK Fields	29 AK Fields	29 AK Fields
Edema Grade 2	3 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields	6 AK Fields	3 AK Fields	3 AK Fields	2 AK Fields	1 AK Fields	0 AK Fields
Edema Grade 3	1 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	3 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 0	25 AK Fields	25 AK Fields	28 AK Fields	28 AK Fields	24 AK Fields	25 AK Fields	25 AK Fields	24 AK Fields	30 AK Fields	30 AK Fields
Edema Grade 1	2 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 Participants Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 Participants ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 Participants Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 Participants ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 Participants Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 Participants ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 Participants Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 Participants ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 Participants Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 0	27 AK Fields	27 AK Fields	27 AK Fields	27 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	29 AK Fields	29 AK Fields
Edema Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Edema Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 0	27 AK Fields	27 AK Fields	28 AK Fields	28 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	30 AK Fields	30 AK Fields
Edema Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Edema Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 0	27 AK Fields	27 AK Fields	29 AK Fields	29 AK Fields	25 AK Fields	25 AK Fields	24 AK Fields	24 AK Fields	29 AK Fields	30 AK Fields
Stinging/Burning Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields
Stinging/Burning Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: During PDT #1

Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 3	3 AK Fields	3 AK Fields	9 AK Fields	7 AK Fields	11 AK Fields	8 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 0	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	2 AK Fields	21 AK Fields	24 AK Fields
Stinging/Burning Grade 1	7 AK Fields	16 AK Fields	5 AK Fields	5 AK Fields	5 AK Fields	6 AK Fields	9 AK Fields	14 AK Fields	9 AK Fields	6 AK Fields
Stinging/Burning Grade 2	16 AK Fields	7 AK Fields	15 AK Fields	17 AK Fields	10 AK Fields	12 AK Fields	13 AK Fields	9 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 minutes after PDT #1

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 0	7 AK Fields	9 AK Fields	5 AK Fields	5 AK Fields	5 AK Fields	7 AK Fields	6 AK Fields	9 AK Fields	28 AK Fields	29 AK Fields
Stinging/Burning Grade 1	12 AK Fields	13 AK Fields	16 AK Fields	19 AK Fields	9 AK Fields	11 AK Fields	16 AK Fields	14 AK Fields	2 AK Fields	1 AK Fields
Stinging/Burning Grade 2	8 AK Fields	5 AK Fields	7 AK Fields	4 AK Fields	11 AK Fields	7 AK Fields	3 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 Hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 0	12 AK Fields	13 AK Fields	7 AK Fields	6 AK Fields	8 AK Fields	9 AK Fields	9 AK Fields	8 AK Fields	28 AK Fields	28 AK Fields
Stinging/Burning Grade 1	8 AK Fields	11 AK Fields	15 AK Fields	16 AK Fields	9 AK Fields	10 AK Fields	6 AK Fields	14 AK Fields	2 AK Fields	2 AK Fields
Stinging/Burning Grade 2	6 AK Fields	3 AK Fields	6 AK Fields	6 AK Fields	8 AK Fields	6 AK Fields	10 AK Fields	3 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 3	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 0	26 AK Fields	26 AK Fields	28 AK Fields	28 AK Fields	25 AK Fields	25 AK Fields	24 AK Fields	24 AK Fields	30 AK Fields	30 AK Fields
Stinging/Burning Grade 1	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 0	27 AK Fields	27 AK Fields	27 AK Fields	27 AK Fields	23 AK Fields	22 AK Fields	24 AK Fields	24 AK Fields	28 AK Fields	29 AK Fields
Stinging/Burning Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields
Stinging/Burning Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Stinging/Burning Grade 0	27 AK Fields	26 AK Fields	27 AK Fields	27 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	24 AK Fields	30 AK Fields	30 AK Fields
Stinging/Burning Grade 1	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Stinging/Burning Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Scaling & Dryness Grade 0	18 AK Fields	18 AK Fields	16 AK Fields	16 AK Fields	17 AK Fields	17 AK Fields	19 AK Fields	19 AK Fields	19 AK Fields	19 AK Fields
Scaling & Dryness Grade 1	7 AK Fields	8 AK Fields	12 AK Fields	10 AK Fields	8 AK Fields	7 AK Fields	5 AK Fields	5 AK Fields	8 AK Fields	8 AK Fields
Scaling & Dryness Grade 2	2 AK Fields	0 AK Fields	1 AK Fields	3 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	3 AK Fields	3 AK Fields
Scaling & Dryness Grade 3	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Scaling & Dryness Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Scaling & Dryness Grade 0	16 AK Fields	17 AK Fields	16 AK Fields	17 AK Fields	17 AK Fields	16 AK Fields	15 AK Fields	15 AK Fields	20 AK Fields	20 AK Fields
Scaling & Dryness Grade 1	7 AK Fields	7 AK Fields	6 AK Fields	7 AK Fields	3 AK Fields	6 AK Fields	7 AK Fields	7 AK Fields	7 AK Fields	8 AK Fields
Scaling & Dryness Grade 2	3 AK Fields	3 AK Fields	4 AK Fields	2 AK Fields	3 AK Fields	2 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields
Scaling & Dryness Grade 3	1 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields
Scaling & Dryness Grade 4	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Scaling & Dryness Grade 0	16 AK Fields	16 AK Fields	20 AK Fields	21 AK Fields	20 AK Fields	21 AK Fields	16 AK Fields	17 AK Fields	22 AK Fields	23 AK Fields
Scaling & Dryness Grade 1	10 AK Fields	7 AK Fields	5 AK Fields	4 AK Fields	3 AK Fields	1 AK Fields	8 AK Fields	7 AK Fields	8 AK Fields	7 AK Fields
Scaling & Dryness Grade 2	1 AK Fields	4 AK Fields	3 AK Fields	3 AK Fields	1 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Scaling & Dryness Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Scaling & Dryness Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Scaling & Dryness Grade 0	20 AK Fields	21 AK Fields	22 AK Fields	22 AK Fields	18 AK Fields	19 AK Fields	19 AK Fields	20 AK Fields	22 AK Fields	22 AK Fields
Scaling & Dryness Grade 1	6 AK Fields	5 AK Fields	3 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields	4 AK Fields	3 AK Fields
Scaling & Dryness Grade 2	1 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	3 AK Fields
Scaling & Dryness Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields
Scaling & Dryness Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Scaling & Dryness Grade 0	23 AK Fields	22 AK Fields	25 AK Fields	24 AK Fields	20 AK Fields	21 AK Fields	23 AK Fields	22 AK Fields	23 AK Fields	23 AK Fields
Scaling & Dryness Grade 1	4 AK Fields	5 AK Fields	3 AK Fields	3 AK Fields	3 AK Fields	2 AK Fields	0 AK Fields	1 AK Fields	6 AK Fields	6 AK Fields
Scaling & Dryness Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Scaling & Dryness Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Scaling & Dryness Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=29 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=29 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=26 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=26 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Oozing/Vesiculation/Crusting Grade 2	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 0	24 AK Fields	25 AK Fields	29 AK Fields	29 AK Fields	24 AK Fields	24 AK Fields	23 AK Fields	24 AK Fields	29 AK Fields	29 AK Fields
Oozing/Vesiculation/Crusting Grade 1	2 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Oozing/Vesiculation/Crusting Grade 0	21 AK Fields	23 AK Fields	24 AK Fields	25 AK Fields	20 AK Fields	19 AK Fields	18 AK Fields	20 AK Fields	29 AK Fields	29 AK Fields
Oozing/Vesiculation/Crusting Grade 1	3 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	4 AK Fields	5 AK Fields	4 AK Fields	2 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 2	2 AK Fields	2 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 3	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=25 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=25 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=25 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Oozing/Vesiculation/Crusting Grade 0	25 AK Fields	26 AK Fields	26 AK Fields	27 AK Fields	24 AK Fields	25 AK Fields	23 AK Fields	24 AK Fields	28 AK Fields	28 AK Fields
Oozing/Vesiculation/Crusting Grade 1	2 AK Fields	0 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 2	0 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=27 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=29 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=29 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Oozing/Vesiculation/Crusting Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 0	25 AK Fields	25 AK Fields	25 AK Fields	26 AK Fields	23 AK Fields	23 AK Fields	23 AK Fields	23 AK Fields	26 AK Fields	26 AK Fields
Oozing/Vesiculation/Crusting Grade 1	1 AK Fields	2 AK Fields	2 AK Fields	1 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 2	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	2 AK Fields	2 AK Fields
Oozing/Vesiculation/Crusting Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

Outcome measures

Outcome measures
Measure	MN + ALA 25 Min 20 mW n=27 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 25 Min 20 mW n=27 AK Fields ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 60 Min 10mW n=28 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 60 Min 10 mW n=28 AK Fields ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + ALA 60 Min 20 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 20 mW n=24 AK Fields ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	MN + ALA 25 Min 10 mW n=24 AK Fields Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	ALA 25 Min 10 mW n=24 AK Fields ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	MN + VEH n=30 AK Fields Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds Microneedle lesion preparation: Microneedling of all visible/palpable AK lesions prior to solution application.	VEH PDT n=30 AK Fields Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Oozing/Vesiculation/Crusting Grade 0	27 AK Fields	27 AK Fields	28 AK Fields	28 AK Fields	23 AK Fields	23 AK Fields	24 AK Fields	24 AK Fields	29 AK Fields	29 AK Fields
Oozing/Vesiculation/Crusting Grade 1	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 2	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	1 AK Fields	1 AK Fields
Oozing/Vesiculation/Crusting Grade 3	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields
Oozing/Vesiculation/Crusting Grade 4	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields	0 AK Fields

Adverse Events

ALA 25 Min 10 mW

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ALA 25 Min 20 mW

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ALA 60 Min 10 mW

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ALA 60 Min 20 mW

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

VEH 60 Min 10 mW

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALA 25 Min 10 mW n=25 participants at risk ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 25 Min 20 mW n=27 participants at risk ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 10 mW n=29 participants at risk ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 60 Min 20 mW n=26 participants at risk ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	VEH 60 Min 10 mW n=30 participants at risk Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Cardiac disorders unstable angina	0.00% 0/25 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/27 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/29 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	3.8% 1/26 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/30 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.

Other adverse events

Other adverse events
Measure	ALA 25 Min 10 mW n=25 participants at risk ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 25 Min 20 mW n=27 participants at risk ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	ALA 60 Min 10 mW n=29 participants at risk ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds	ALA 60 Min 20 mW n=26 participants at risk ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. ALA: 20% ALA applied to face prior to light treatment MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to ALA application. IBL 20 mW: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds	VEH 60 Min 10 mW n=30 participants at risk Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. MN: one AK Field (1/2 face) on each subject randomized to microneedle lesion preparation prior to VEH application. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment IBL 10 mW: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/27 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	3.4% 1/29 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/26 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	6.7% 2/30 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.
Injury, poisoning and procedural complications Pain	4.0% 1/25 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	3.7% 1/27 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	10.3% 3/29 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	26.9% 7/26 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.	0.00% 0/30 • 3 months This was a split face study where one AK Field on a subjects was randomized to MN lesion pretreatment and the other AK Field was randomized to no pretreatment, but both Fields received the same drug/light treatment. Local skin tolerability effects were presented separately for +MN and -MN, but AEs were evaluated on a per SUBJECT basis, not on a per FIELD basis.

Additional Information

Anna Houlihan

DUSA Pharmaceuticals Inc., a Sun Pharma Co.

Phone: 9147608796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee First publication of results will be made by the Sponsor. If publication is not submitted within 12 months after the date of study final report, the PI may publish the results from the site individually, subject to compliance with the other terms of the clinical trial agreement, including a requirement that the PI provide a draft of the publication for the sponsor's review 30 days before submission for publication so that sponsor can review the publication for confidential information
Publication restrictions are in place

Restriction type: OTHER