Trial Outcomes & Findings for Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy (NCT NCT02239679)

Results Overview

Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

166 participants

Primary outcome timeframe

Week 52

Results posted on

2018-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	ALA X2 Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.	ALA X3 Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Overall Study STARTED	53	59	54
Overall Study COMPLETED	50	56	53
Overall Study NOT COMPLETED	3	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ALA X2 Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.	ALA X3 Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	2	3	1

Baseline Characteristics

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	Total n=166 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 9.65 • n=5 Participants	66.7 years STANDARD_DEVIATION 9.35 • n=7 Participants	65.8 years STANDARD_DEVIATION 9.5 • n=5 Participants	66.8 years STANDARD_DEVIATION 9.48 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	44 Participants n=5 Participants	135 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	59 Participants n=7 Participants	53 Participants n=5 Participants	164 Participants n=4 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
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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
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
Race (NIH/OMB) White	53 Participants n=5 Participants	59 Participants n=7 Participants	54 Participants n=5 Participants	166 Participants n=4 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
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
Region of Enrollment United States	53 Participants n=5 Participants	59 Participants n=7 Participants	54 Participants n=5 Participants	166 Participants n=4 Participants
Skin Type Skin Type I - Burns easily, never tans	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Skin Type Skin Type II - Burns easily, tans minimally	29 Participants n=5 Participants	37 Participants n=7 Participants	35 Participants n=5 Participants	101 Participants n=4 Participants
Skin Type Skin Type III - Burns moderately, tans gradually	16 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	40 Participants n=4 Participants
Skin Type Skin Type IV - Burns minimally, tans well	2 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Skin Type Skin Type V - Rarely burns, tans profusely	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.

Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Total Number of AKs in Treatment Area	3.0 lesions Standard Error 0.91	2.1 lesions Standard Error 0.84	4.7 lesions Standard Error 0.86

SECONDARY outcome

Timeframe: Week 4

Population: Analysis population consisted of observed data; ie. subjects with data at Week 4.

Normalized based on number of lesions present at Baseline

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Proportion of Subjects With 0 AKs	35 Participants	35 Participants	27 Participants

SECONDARY outcome

Timeframe: Week 52

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

Outcome measures

Outcome measures
Measure	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Subject Satisfaction Score Very Satisfied	27 Participants	26 Participants	16 Participants
Subject Satisfaction Score Moderately Satisfied	15 Participants	21 Participants	14 Participants
Subject Satisfaction Score Slightly Satisfied	7 Participants	9 Participants	14 Participants
Subject Satisfaction Score Not Satisfied	2 Participants	0 Participants	9 Participants
Subject Satisfaction Score Unknown	2 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Analysis population consisted of observed data; ie. subjects with data at Week 12.

Normalized based on number of lesions present at Baseline

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Proportion of Subjects With 0 AKs	27 Participants	35 Participants	22 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Analysis population consisted of observed data only.

Normalized based on number of lesions present at Baseline

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Proportion of Subjects With 0 AKs	30 Participants	22 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 36

Population: Analysis population consisted of observed data only

Normalized based on number of lesions present at Baseline

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Proportion of Subjects With 0 AKs	15 Participants	20 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Analysis population consisted of observed data only

Normalized based on number of lesions present at Baseline

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Proportion of Subjects With 0 AKs	18 Participants	21 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Analysis population consisted of observed data only

Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).

Outcome measures

Outcome measures
Measure	ALA X2 n=441 number of lesions Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=525 number of lesions Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=522 number of lesions Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Recurrence Rate	34 number of lesions	32 number of lesions	81 number of lesions

SECONDARY outcome

Timeframe: within 52 weeks after Baseline

Population: Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.

Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Duration of Response	35.9 weeks Standard Deviation 20.4	33.3 weeks Standard Deviation 19.7	25.9 weeks Standard Deviation 20.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	22 Participants	27 Participants	25 Participants
Hyperpigmentation Grade 1	17 Participants	23 Participants	20 Participants
Hyperpigmentation Grade 2	13 Participants	5 Participants	8 Participants
Hyperpigmentation Grade 3	1 Participants	3 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	23 Participants	26 Participants	22 Participants
Hyperpigmentation Grade 1	17 Participants	25 Participants	22 Participants
Hyperpigmentation Grade 2	12 Participants	5 Participants	9 Participants
Hyperpigmentation Grade 3	1 Participants	2 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after photodynamic therapy (PDT) #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	23 Participants	22 Participants	23 Participants
Hyperpigmentation Grade 1	14 Participants	24 Participants	21 Participants
Hyperpigmentation Grade 2	13 Participants	10 Participants	8 Participants
Hyperpigmentation Grade 3	3 Participants	0 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	21 Participants	26 Participants	23 Participants
Hyperpigmentation Grade 1	21 Participants	25 Participants	23 Participants
Hyperpigmentation Grade 2	8 Participants	4 Participants	7 Participants
Hyperpigmentation Grade 3	1 Participants	1 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	22 Participants	28 Participants	23 Participants
Hyperpigmentation Grade 1	21 Participants	22 Participants	23 Participants
Hyperpigmentation Grade 2	8 Participants	5 Participants	6 Participants
Hyperpigmentation Grade 3	0 Participants	1 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	25 Participants	26 Participants	24 Participants
Hyperpigmentation Grade 1	18 Participants	24 Participants	23 Participants
Hyperpigmentation Grade 2	8 Participants	4 Participants	5 Participants
Hyperpigmentation Grade 3	0 Participants	1 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	24 Participants	25 Participants	24 Participants
Hyperpigmentation Grade 1	19 Participants	26 Participants	23 Participants
Hyperpigmentation Grade 2	7 Participants	3 Participants	5 Participants
Hyperpigmentation Grade 3	0 Participants	1 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hyperpigmentation Grade 0	22 Participants	24 Participants	24 Participants
Hyperpigmentation Grade 1	21 Participants	25 Participants	23 Participants
Hyperpigmentation Grade 2	7 Participants	5 Participants	5 Participants
Hyperpigmentation Grade 3	0 Participants	1 Participants	1 Participants
Hyperpigmentation Grade 4	0 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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

Outcome measures

Outcome measures
Measure	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	35 Participants	40 Participants	38 Participants
Hypopigmentation Grade 1	16 Participants	17 Participants	14 Participants
Hypopigmentation Grade 2	2 Participants	2 Participants	2 Participants
Hypopigmentation Grade 3	0 Participants	0 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

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

Outcome measures

Outcome measures
Measure	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	37 Participants	38 Participants	37 Participants
Hypopigmentation Grade 1	14 Participants	19 Participants	14 Participants
Hypopigmentation Grade 2	2 Participants	2 Participants	3 Participants
Hypopigmentation Grade 3	0 Participants	0 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 1	14 Participants	19 Participants	16 Participants
Hypopigmentation Grade 2	4 Participants	2 Participants	2 Participants
Hypopigmentation Grade 0	34 Participants	35 Participants	35 Participants
Hypopigmentation Grade 3	1 Participants	1 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	34 Participants	38 Participants	35 Participants
Hypopigmentation Grade 1	14 Participants	17 Participants	17 Participants
Hypopigmentation Grade 2	3 Participants	2 Participants	2 Participants
Hypopigmentation Grade 3	0 Participants	0 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	33 Participants	40 Participants	35 Participants
Hypopigmentation Grade 1	14 Participants	15 Participants	17 Participants
Hypopigmentation Grade 2	4 Participants	1 Participants	1 Participants
Hypopigmentation Grade 3	0 Participants	1 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	33 Participants	39 Participants	37 Participants
Hypopigmentation Grade 1	16 Participants	15 Participants	15 Participants
Hypopigmentation Grade 2	2 Participants	1 Participants	1 Participants
Hypopigmentation Grade 3	0 Participants	1 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	31 Participants	38 Participants	35 Participants
Hypopigmentation Grade 1	18 Participants	16 Participants	17 Participants
Hypopigmentation Grade 2	1 Participants	1 Participants	1 Participants
Hypopigmentation Grade 3	0 Participants	1 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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

Outcome measures

Outcome measures
Measure	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Hypopigmentation Grade 0	26 Participants	35 Participants	33 Participants
Hypopigmentation Grade 1	22 Participants	19 Participants	19 Participants
Hypopigmentation Grade 2	2 Participants	1 Participants	1 Participants
Hypopigmentation Grade 3	0 Participants	1 Participants	0 Participants
Hypopigmentation Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	31 Participants	41 Participants	33 Participants
Erythema Grade 1	16 Participants	13 Participants	13 Participants
Erythema Grade 2	6 Participants	4 Participants	8 Participants
Erythema Grade 3	0 Participants	1 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	34 Participants	38 Participants	33 Participants
Erythema Grade 1	14 Participants	18 Participants	15 Participants
Erythema Grade 2	5 Participants	3 Participants	6 Participants
Erythema Grade 3	0 Participants	0 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 3	12 Participants	17 Participants	4 Participants
Erythema Grade 0	4 Participants	6 Participants	11 Participants
Erythema Grade 1	8 Participants	11 Participants	27 Participants
Erythema Grade 2	29 Participants	25 Participants	12 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 1	12 Participants	10 Participants	21 Participants
Erythema Grade 2	13 Participants	14 Participants	8 Participants
Erythema Grade 3	23 Participants	26 Participants	2 Participants
Erythema Grade 4	3 Participants	4 Participants	0 Participants
Erythema Grade 0	2 Participants	3 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	35 Participants	41 Participants	34 Participants
Erythema Grade 1	14 Participants	14 Participants	15 Participants
Erythema Grade 2	2 Participants	2 Participants	5 Participants
Erythema Grade 3	0 Participants	0 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 1	16 Participants	13 Participants	15 Participants
Erythema Grade 2	0 Participants	1 Participants	1 Participants
Erythema Grade 3	0 Participants	0 Participants	1 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants
Erythema Grade 0	35 Participants	43 Participants	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	37 Participants	41 Participants	31 Participants
Erythema Grade 1	14 Participants	13 Participants	20 Participants
Erythema Grade 2	0 Participants	2 Participants	2 Participants
Erythema Grade 3	0 Participants	0 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	37 Participants	36 Participants	33 Participants
Erythema Grade 1	13 Participants	19 Participants	18 Participants
Erythema Grade 2	0 Participants	1 Participants	2 Participants
Erythema Grade 3	0 Participants	0 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Erythema Grade 0	38 Participants	40 Participants	37 Participants
Erythema Grade 1	11 Participants	14 Participants	14 Participants
Erythema Grade 2	1 Participants	2 Participants	2 Participants
Erythema Grade 3	0 Participants	0 Participants	0 Participants
Erythema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	52 Participants	59 Participants	54 Participants
Edema Grade 1	1 Participants	0 Participants	0 Participants
Edema Grade 2	0 Participants	0 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	53 Participants	59 Participants	54 Participants
Edema Grade 1	0 Participants	0 Participants	0 Participants
Edema Grade 2	0 Participants	0 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	46 Participants	44 Participants	52 Participants
Edema Grade 1	6 Participants	12 Participants	2 Participants
Edema Grade 2	1 Participants	2 Participants	0 Participants
Edema Grade 3	0 Participants	1 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	33 Participants	31 Participants	53 Participants
Edema Grade 1	14 Participants	16 Participants	0 Participants
Edema Grade 2	6 Participants	10 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	51 Participants	56 Participants	53 Participants
Edema Grade 1	0 Participants	0 Participants	1 Participants
Edema Grade 2	0 Participants	1 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	51 Participants	57 Participants	53 Participants
Edema Grade 1	0 Participants	0 Participants	0 Participants
Edema Grade 2	0 Participants	0 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	51 Participants	56 Participants	53 Participants
Edema Grade 1	0 Participants	0 Participants	0 Participants
Edema Grade 2	0 Participants	0 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	49 Participants	55 Participants	51 Participants
Edema Grade 1	1 Participants	1 Participants	1 Participants
Edema Grade 2	0 Participants	0 Participants	1 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Edema Grade 0	50 Participants	56 Participants	53 Participants
Edema Grade 1	0 Participants	0 Participants	0 Participants
Edema Grade 2	0 Participants	0 Participants	0 Participants
Edema Grade 3	0 Participants	0 Participants	0 Participants
Edema Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 4	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 0	53 Participants	58 Participants	53 Participants
Stinging/Burning Grade 1	0 Participants	1 Participants	1 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	53 Participants	59 Participants	53 Participants
Stinging/Burning Grade 1	0 Participants	0 Participants	1 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 4	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	5 Participants	5 Participants	42 Participants
Stinging/Burning Grade 1	18 Participants	21 Participants	11 Participants
Stinging/Burning Grade 2	27 Participants	32 Participants	1 Participants
Stinging/Burning Grade 3	3 Participants	1 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	11 Participants	11 Participants	46 Participants
Stinging/Burning Grade 1	33 Participants	37 Participants	8 Participants
Stinging/Burning Grade 2	9 Participants	11 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 1	17 Participants	29 Participants	2 Participants
Stinging/Burning Grade 2	5 Participants	5 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 0	31 Participants	23 Participants	51 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	51 Participants	57 Participants	53 Participants
Stinging/Burning Grade 1	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	1 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	51 Participants	57 Participants	52 Participants
Stinging/Burning Grade 1	0 Participants	0 Participants	1 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	51 Participants	55 Participants	53 Participants
Stinging/Burning Grade 1	0 Participants	1 Participants	0 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	49 Participants	56 Participants	51 Participants
Stinging/Burning Grade 1	0 Participants	0 Participants	2 Participants
Stinging/Burning Grade 2	1 Participants	0 Participants	0 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Stinging/Burning Grade 0	49 Participants	56 Participants	52 Participants
Stinging/Burning Grade 1	1 Participants	0 Participants	0 Participants
Stinging/Burning Grade 2	0 Participants	0 Participants	1 Participants
Stinging/Burning Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	41 Participants	43 Participants	40 Participants
Scaling & Dryness Grade 1	8 Participants	11 Participants	11 Participants
Scaling & Dryness Grade 2	4 Participants	4 Participants	3 Participants
Scaling & Dryness Grade 3	0 Participants	1 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 2	4 Participants	3 Participants	4 Participants
Scaling & Dryness Grade 3	1 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 0	38 Participants	44 Participants	39 Participants
Scaling & Dryness Grade 1	10 Participants	12 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	30 Participants	35 Participants	38 Participants
Scaling & Dryness Grade 1	18 Participants	14 Participants	13 Participants
Scaling & Dryness Grade 2	4 Participants	7 Participants	2 Participants
Scaling & Dryness Grade 3	1 Participants	1 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	41 Participants	46 Participants	41 Participants
Scaling & Dryness Grade 1	10 Participants	10 Participants	11 Participants
Scaling & Dryness Grade 2	0 Participants	1 Participants	2 Participants
Scaling & Dryness Grade 3	0 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	40 Participants	44 Participants	43 Participants
Scaling & Dryness Grade 1	10 Participants	11 Participants	7 Participants
Scaling & Dryness Grade 2	0 Participants	2 Participants	2 Participants
Scaling & Dryness Grade 3	1 Participants	0 Participants	1 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	43 Participants	46 Participants	39 Participants
Scaling & Dryness Grade 1	6 Participants	8 Participants	12 Participants
Scaling & Dryness Grade 2	2 Participants	2 Participants	2 Participants
Scaling & Dryness Grade 3	0 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 2	1 Participants	2 Participants	2 Participants
Scaling & Dryness Grade 0	38 Participants	46 Participants	38 Participants
Scaling & Dryness Grade 1	11 Participants	8 Participants	13 Participants
Scaling & Dryness Grade 3	0 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Scaling & Dryness Grade 0	42 Participants	42 Participants	47 Participants
Scaling & Dryness Grade 1	6 Participants	10 Participants	4 Participants
Scaling & Dryness Grade 2	2 Participants	4 Participants	2 Participants
Scaling & Dryness Grade 3	0 Participants	0 Participants	0 Participants
Scaling & Dryness Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 0	53 Participants	58 Participants	53 Participants
Oozing/Vesiculation/Crusting Grade 1	0 Participants	1 Participants	1 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 0	49 Participants	58 Participants	51 Participants
Oozing/Vesiculation/Crusting Grade 1	4 Participants	1 Participants	2 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	1 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=53 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 1	3 Participants	3 Participants	3 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	1 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	1 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 0	50 Participants	53 Participants	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 0	51 Participants	56 Participants	51 Participants
Oozing/Vesiculation/Crusting Grade 1	0 Participants	1 Participants	2 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	1 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=57 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 1	1 Participants	1 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 0	50 Participants	56 Participants	53 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=51 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 0	50 Participants	56 Participants	53 Participants
Oozing/Vesiculation/Crusting Grade 1	1 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 0	50 Participants	56 Participants	52 Participants
Oozing/Vesiculation/Crusting Grade 1	0 Participants	0 Participants	1 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 52 Weeks after PDT #1

Population: Analysis population consisted of observed data only

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	ALA X2 n=50 Participants Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=56 Participants Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=53 Participants Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Oozing/Vesiculation/Crusting Grade 0	49 Participants	56 Participants	53 Participants
Oozing/Vesiculation/Crusting Grade 1	1 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 2	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 3	0 Participants	0 Participants	0 Participants
Oozing/Vesiculation/Crusting Grade 4	0 Participants	0 Participants	0 Participants

Adverse Events

ALA X2

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

ALA X3

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

VEH-PDT

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALA X2 n=53 participants at risk Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 participants at risk Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 participants at risk Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Cardiac disorders acute myocardial infarction	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	1.9% 1/54 • 52 weeks
Cardiac disorders angina unstable	0.00% 0/53 • 52 weeks	1.7% 1/59 • 52 weeks	0.00% 0/54 • 52 weeks
Cardiac disorders atrial fibrillation	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	1.9% 1/54 • 52 weeks
Cardiac disorders coronary artery disease	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	1.9% 1/54 • 52 weeks
Ear and labyrinth disorders vertigo	0.00% 0/53 • 52 weeks	1.7% 1/59 • 52 weeks	0.00% 0/54 • 52 weeks
Gastrointestinal disorders upper gastrointestinal haemorrhage	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	1.9% 1/54 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) duodenal neoplasm	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	1.9% 1/54 • 52 weeks
Nervous system disorders headache	0.00% 0/53 • 52 weeks	1.7% 1/59 • 52 weeks	0.00% 0/54 • 52 weeks

Other adverse events

Other adverse events
Measure	ALA X2 n=53 participants at risk Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	ALA X3 n=59 participants at risk Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.	VEH-PDT n=54 participants at risk Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2 Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.
Injury, poisoning and procedural complications procedural pain	0.00% 0/53 • 52 weeks	1.7% 1/59 • 52 weeks	5.6% 3/54 • 52 weeks
Musculoskeletal and connective tissue disorders back pain	0.00% 0/53 • 52 weeks	0.00% 0/59 • 52 weeks	5.6% 3/54 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) basal cell carcinoma	17.0% 9/53 • 52 weeks	8.5% 5/59 • 52 weeks	7.4% 4/54 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma	5.7% 3/53 • 52 weeks	1.7% 1/59 • 52 weeks	0.00% 0/54 • 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma of skin	11.3% 6/53 • 52 weeks	5.1% 3/59 • 52 weeks	14.8% 8/54 • 52 weeks

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