Trial Outcomes & Findings for Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne (NCT NCT00706433)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

266 participants

Primary outcome timeframe

Baseline and 3 weeks after final treatment

Results posted on

2011-10-24

Participant Flow

Recruitment period: 3/7/07 - 3/31/08 Types of location: medical clinics

no enrolled participants excluded from the trial before assignment to groups

Participant milestones

Participant milestones
Measure	ALA 1000 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Study STARTED	68	65	67	66
Overall Study COMPLETED	63	62	57	64
Overall Study NOT COMPLETED	5	3	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ALA 1000 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Overall Study Lost to Follow-up	3	1	6	0
Overall Study Withdrawal by Subject	1	2	3	1
Overall Study Adverse Event	0	0	1	0
Overall Study Protocol Violation	1	0	0	0
Overall Study new job	0	0	0	1

Baseline Characteristics

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)	Total n=266 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=5 Participants	44 Participants n=7 Participants	33 Participants n=5 Participants	37 Participants n=4 Participants	155 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	21 Participants n=7 Participants	34 Participants n=5 Participants	29 Participants n=4 Participants	111 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	20.0 years STANDARD_DEVIATION 6.15 • n=5 Participants	19.4 years STANDARD_DEVIATION 6.82 • n=7 Participants	21.3 years STANDARD_DEVIATION 6.77 • n=5 Participants	19.8 years STANDARD_DEVIATION 5.31 • n=4 Participants	20.1 years STANDARD_DEVIATION 6.3 • n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	38 Participants n=5 Participants	35 Participants n=4 Participants	138 Participants n=21 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	31 Participants n=4 Participants	128 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	58 Participants n=7 Participants	56 Participants n=5 Participants	57 Participants n=4 Participants	227 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Edema Grade 0 (none)	65 participants n=5 Participants	64 participants n=7 Participants	65 participants n=5 Participants	65 participants n=4 Participants	259 participants n=21 Participants
Edema Grade 1 (minimal)	3 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants
Erythema Grade 0 (none)	37 participants n=5 Participants	34 participants n=7 Participants	41 participants n=5 Participants	36 participants n=4 Participants	148 participants n=21 Participants
Erythema Grade 1 (minimal)	24 participants n=5 Participants	20 participants n=7 Participants	16 participants n=5 Participants	21 participants n=4 Participants	81 participants n=21 Participants
Erythema Grade 2 (mild)	6 participants n=5 Participants	11 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	34 participants n=21 Participants
Erythema Grade 3 (moderate)	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Fitzpatrick Skin Type Type I - never tans (sensitive)	0 participant n=5 Participants	3 participant n=7 Participants	2 participant n=5 Participants	3 participant n=4 Participants	8 participant n=21 Participants
Fitzpatrick Skin Type Type II - tans minimally (sensitive)	16 participant n=5 Participants	13 participant n=7 Participants	14 participant n=5 Participants	19 participant n=4 Participants	62 participant n=21 Participants
Fitzpatrick Skin Type Type III - tans gradually (light brown)(normal)	24 participant n=5 Participants	24 participant n=7 Participants	24 participant n=5 Participants	15 participant n=4 Participants	87 participant n=21 Participants
Fitzpatrick Skin Type Type IV - always tans well (moderate brown)	17 participant n=5 Participants	15 participant n=7 Participants	15 participant n=5 Participants	16 participant n=4 Participants	63 participant n=21 Participants
Fitzpatrick Skin Type Type V - tans profusely (dark brown)	7 participant n=5 Participants	4 participant n=7 Participants	6 participant n=5 Participants	10 participant n=4 Participants	27 participant n=21 Participants
Fitzpatrick Skin Type Type VI - deeply pigmented (insensitive)	4 participant n=5 Participants	6 participant n=7 Participants	6 participant n=5 Participants	3 participant n=4 Participants	19 participant n=21 Participants
Hyperpigmentation Grade 0 (none)	50 participants n=5 Participants	48 participants n=7 Participants	49 participants n=5 Participants	53 participants n=4 Participants	200 participants n=21 Participants
Hyperpigmentation Grade 1 (light)	12 participants n=5 Participants	16 participants n=7 Participants	12 participants n=5 Participants	6 participants n=4 Participants	46 participants n=21 Participants
Hyperpigmentation Grade 2 (moderate - small)	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	16 participants n=21 Participants
Hyperpigmentation Grade 3 (moderate - moderate)	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants
Hypopigmentation Grade 0 (none)	65 participants n=5 Participants	65 participants n=7 Participants	67 participants n=5 Participants	64 participants n=4 Participants	261 participants n=21 Participants
Hypopigmentation Grade 1 (light)	3 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants
Investigator Global Assessment of Acne Severity Grade 3 (moderate severity)	28 participants n=5 Participants	37 participants n=7 Participants	31 participants n=5 Participants	31 participants n=4 Participants	127 participants n=21 Participants
Investigator Global Assessment of Acne Severity Grade 4 (severe)	40 participants n=5 Participants	28 participants n=7 Participants	36 participants n=5 Participants	35 participants n=4 Participants	139 participants n=21 Participants
Oozing/vesiculation.crusting Grade 0 (none)	62 participants n=5 Participants	62 participants n=7 Participants	63 participants n=5 Participants	64 participants n=4 Participants	251 participants n=21 Participants
Oozing/vesiculation.crusting Grade 1 (minimal)	3 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants
Oozing/vesiculation.crusting Grade 2 (mild)	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	0 participants n=4 Participants	6 participants n=21 Participants
Scaling and Dryness Grade 0 (none)	53 participants n=5 Participants	47 participants n=7 Participants	44 participants n=5 Participants	46 participants n=4 Participants	190 participants n=21 Participants
Scaling and Dryness Grade 1 (minimal)	13 participants n=5 Participants	14 participants n=7 Participants	20 participants n=5 Participants	17 participants n=4 Participants	64 participants n=21 Participants
Scaling and Dryness Grade 2 (mild)	2 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants
Scaling and Dryness Grade 3 (moderate)	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Scaling and Dryness Grade 4 (severe)	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Stinging/Burning Grade 0 (none)	64 participant n=5 Participants	63 participant n=7 Participants	66 participant n=5 Participants	63 participant n=4 Participants	256 participant n=21 Participants
Stinging/Burning Grade 1 (minimal)	4 participant n=5 Participants	2 participant n=7 Participants	1 participant n=5 Participants	3 participant n=4 Participants	10 participant n=21 Participants
Number of Inflammatory Lesions	50.0 lesions STANDARD_DEVIATION 35.8 • n=5 Participants	44.0 lesions STANDARD_DEVIATION 27.0 • n=7 Participants	49.0 lesions STANDARD_DEVIATION 34.8 • n=5 Participants	41.5 lesions STANDARD_DEVIATION 26.6 • n=4 Participants	44.5 lesions STANDARD_DEVIATION 31.4 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 3 weeks after final treatment

Population: ITT analysis, LOCF

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Change in Inflammatory Lesion Counts Relative to Baseline	-18.0 change in lesion count Standard Deviation 26.3	-14.0 change in lesion count Standard Deviation 26.8	-19.0 change in lesion count Standard Deviation 22.8	-14.5 change in lesion count Standard Deviation 24.0

PRIMARY outcome

Timeframe: Baseline and 3 weeks after final treatment

Population: ITT LOCF

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Investigator Global Assessment of Acne Severity Successes Success	13 participants	11 participants	15 participants	11 participants
Investigator Global Assessment of Acne Severity Successes Failure	55 participants	54 participants	52 participants	55 participants

SECONDARY outcome

Timeframe: Baseline and 3 weeks after final treatment

Population: ITT LOCF

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Percent Change in Inflammatory Lesion Counts Relative to Baseline	-37.5 percent change in lesion count Standard Deviation 38.79	-29.2 percent change in lesion count Standard Deviation 46.68	-41.7 percent change in lesion count Standard Deviation 38.82	-37.0 percent change in lesion count Standard Deviation 40.23

SECONDARY outcome

Timeframe: Baseline and 6 weeks after final treatment

Population: ITT LOCF

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Percent Change in Inflammatory Lesion Counts Relative to Baseline	-34.4 percent change in lesion count Standard Deviation 37.8	-29.0 percent change in lesion count Standard Deviation 42.57	-48.4 percent change in lesion count Standard Deviation 32.81	-45.2 percent change in lesion count Standard Deviation 50.15

SECONDARY outcome

Timeframe: 6 weeks after final treatment

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=64 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=58 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Subject Satisfaction Score Excellent	23 participants	11 participants	23 participants	26 participants
Subject Satisfaction Score Good	18 participants	28 participants	20 participants	23 participants
Subject Satisfaction Score Fair	17 participants	17 participants	11 participants	12 participants
Subject Satisfaction Score Poor	6 participants	5 participants	4 participants	5 participants

SECONDARY outcome

Timeframe: Baseline and 6 weeks after final treatment

Population: ITT LOCF

change in lesion counts compared to baseline

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Change in Inflammatory Lesion Counts Relative to Baseline	-18.5 change in lesion count Standard Deviation 30.15	-13.0 change in lesion count Standard Deviation 28.74	-21.0 change in lesion count Standard Deviation 23.63	-17.0 change in lesion count Standard Deviation 26.71

SECONDARY outcome

Timeframe: Baesline and 6 weeks after final treatment

Population: ITT LOCF

Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Investigator Global Assessment of Acne Severity Successes Success	15 participants	11 participants	16 participants	16 participants
Investigator Global Assessment of Acne Severity Successes Failure	53 participants	54 participants	51 participants	50 participants

SECONDARY outcome

Timeframe: 48 hours after PDT #1

Population: ITT, observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation 48 Hours After PDT #1 Grade 0 (none)	49 participants	49 participants	49 participants	53 participants
Hyperpigmentation 48 Hours After PDT #1 Grade 1 (light)	14 participants	14 participants	10 participants	7 participants
Hyperpigmentation 48 Hours After PDT #1 Grade 2 (moderate - small)	4 participants	1 participants	7 participants	3 participants
Hyperpigmentation 48 Hours After PDT #1 Grade 3 (moderate - mod)	1 participants	0 participants	0 participants	3 participants
Hyperpigmentation 48 Hours After PDT #1 Grade 4 (marked)	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3)

Population: ITT, observed

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 1000 Seconds n=64 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation at Visit 3 (Week 3) Grade 0 (none)	49 participants	50 participants	48 participants	52 participants
Hyperpigmentation at Visit 3 (Week 3) Grade 1 (light)	10 participants	10 participants	10 participants	8 participants
Hyperpigmentation at Visit 3 (Week 3) Grade 2 (moderate - small)	4 participants	2 participants	4 participants	4 participants
Hyperpigmentation at Visit 3 (Week 3) Grade 3 (moderate - mod)	1 participants	0 participants	0 participants	2 participants
Hyperpigmentation at Visit 3 (Week 3) Grade 4 (marked)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6)

Population: ITT, observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation at Visit 5 (Week 6) Grade 0 (none)	44 participants	51 participants	46 participants	49 participants
Hyperpigmentation at Visit 5 (Week 6) Grade 1 (light)	13 participants	9 participants	12 participants	8 participants
Hyperpigmentation at Visit 5 (Week 6) Grade 2 (moderate - small)	3 participants	3 participants	2 participants	4 participants
Hyperpigmentation at Visit 5 (Week 6) Grade 3 (moderate - mod)	2 participants	0 participants	0 participants	2 participants
Hyperpigmentation at Visit 5 (Week 6) Grade 4 (marked)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9)

Population: ITT, observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation at Visit 7 (Week 9) Grade 0 (none)	49 participant	49 participant	45 participant	52 participant
Hyperpigmentation at Visit 7 (Week 9) Grade 1 (light)	9 participant	11 participant	11 participant	10 participant
Hyperpigmentation at Visit 7 (Week 9) Grade 2 (moderate - small)	4 participant	2 participant	1 participant	3 participant
Hyperpigmentation at Visit 7 (Week 9) Grade 3 (moderate - mod)	1 participant	0 participant	0 participant	0 participant
Hyperpigmentation at Visit 7 (Week 9) Grade 4 (marked)	0 participant	0 participant	0 participant	0 participant

SECONDARY outcome

Timeframe: Visit 9 (3 weeks after final PDT)

Population: ITT, observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) Grade 0 (none)	45 participants	49 participants	43 participants	51 participants
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) Grade 1 (light)	12 participants	10 participants	11 participants	7 participants
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) Grade 2 (moderate - small)	5 participants	2 participants	3 participants	5 participants
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) Grade 3 (moderate - mod)	0 participants	0 participants	0 participants	0 participants
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) Grade 4 (marked)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 10 (6 weeks after final PDT)

Population: ITT, observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=64 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) Grade 0 (none)	48 participants	50 participants	46 participants	50 participants
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) Grade 1 (light)	12 participants	9 participants	7 participants	10 participants
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) Grade 2 (moderate - small)	1 participants	2 participants	4 participants	3 participants
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) Grade 3 (moderate - mod)	2 participants	1 participants	0 participants	1 participants
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) Grade 4 (marked)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 48 hours post PDT #1

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation 48 Hours Post PDT #1 Grade 0 (none)	67 participants	64 participants	65 participants	64 participants
Hypopigmentation 48 Hours Post PDT #1 Grade 1 (light)	1 participants	1 participants	0 participants	2 participants
Hypopigmentation 48 Hours Post PDT #1 Grade 2 (moderate - small)	0 participants	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3)

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=64 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation at Visit 3 (Week 3) Grade 0 (none)	61 participants	62 participants	61 participants	65 participants
Hypopigmentation at Visit 3 (Week 3) Grade 1 (light)	2 participants	0 participants	1 participants	1 participants
Hypopigmentation at Visit 3 (Week 3) Grade 2 (moderate - small)	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6)

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation at Visit 5 (Week 6) Grade 0 (none)	59 participants	63 participants	60 participants	63 participants
Hypopigmentation at Visit 5 (Week 6) Grade 1 (light)	3 participants	0 participants	0 participants	0 participants
Hypopigmentation at Visit 5 (Week 6) Grade 2 (moderate - small)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9)

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation at Visit 7 (Week 9) Grade 0 (none)	61 participants	62 participants	57 participants	65 participants
Hypopigmentation at Visit 7 (Week 9) Grade 1 (light)	2 participants	0 participants	0 participants	0 participants
Hypopigmentation at Visit 7 (Week 9) Grade 2 (moderate - small)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 9 (3 weeks after final PDT)

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation at Visit 9 (3 Weeks After Final PDT) Grade 0 (none)	58 participants	61 participants	57 participants	63 participants
Hypopigmentation at Visit 9 (3 Weeks After Final PDT) Grade 1 (light)	4 participants	0 participants	0 participants	0 participants
Hypopigmentation at Visit 9 (3 Weeks After Final PDT) Grade 2 (moderate - small)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 10 (6 weeks after final PDT)

Population: ITT, observed

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

Outcome measures

Outcome measures
Measure	ALA 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=64 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Hypopigmentation at Visit 10 (6 Weeks After Final PDT) Grade 0 (none)	60 participants	62 participants	57 participants	64 participants
Hypopigmentation at Visit 10 (6 Weeks After Final PDT) Grade 1 (light)	2 participants	0 participants	0 participants	0 participants
Hypopigmentation at Visit 10 (6 Weeks After Final PDT) Grade 2 (moderate - small)	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (pre-light)

Population: ITT, observed

After solution application, prior to light treatment 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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Baseline (Pre-light) Grade 0 (none)	29 participants	31 participants	35 participants	29 participants
Erythema at Baseline (Pre-light) Grade 1 (minimal)	24 participants	20 participants	19 participants	25 participants
Erythema at Baseline (Pre-light) Grade 2 (mild)	13 participants	13 participants	12 participants	12 participants
Erythema at Baseline (Pre-light) Grade 3 (moderate)	2 participants	1 participants	1 participants	0 participants
Erythema at Baseline (Pre-light) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline - post light treatment

Population: ITT observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Baseline - Post Light Treatment Grade 0 (none)	16 participants	18 participants	22 participants	21 participants
Erythema at Baseline - Post Light Treatment Grade 1 (minimal)	23 participants	24 participants	19 participants	27 participants
Erythema at Baseline - Post Light Treatment Grade 2 (mild)	26 participants	16 participants	22 participants	15 participants
Erythema at Baseline - Post Light Treatment Grade 3 (moderate)	3 participants	7 participants	4 participants	3 participants
Erythema at Baseline - Post Light Treatment Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 48 hours after PDT #1

Population: ITT, observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema 48 Hours After PDT #1 Grade 0 (none)	19 participants	16 participants	34 participants	29 participants
Erythema 48 Hours After PDT #1 Grade 1 (minimal)	24 participants	21 participants	25 participants	30 participants
Erythema 48 Hours After PDT #1 Grade 2 (mild)	14 participants	23 participants	6 participants	7 participants
Erythema 48 Hours After PDT #1 Grade 3 (moderate)	10 participants	3 participants	1 participants	0 participants
Erythema 48 Hours After PDT #1 Grade 4 (severe)	1 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - pre study drug application)

Population: ITT, observed

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 1000 Seconds n=64 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 3 (Week 3 - Pre Study Drug Application) Grade 0 (none)	36 participants	35 participants	34 participants	34 participants
Erythema at Visit 3 (Week 3 - Pre Study Drug Application) Grade 1 (minimal)	20 participants	16 participants	23 participants	23 participants
Erythema at Visit 3 (Week 3 - Pre Study Drug Application) Grade 2 (mild)	8 participants	11 participants	5 participants	9 participants
Erythema at Visit 3 (Week 3 - Pre Study Drug Application) Grade 3 (moderate)	0 participants	0 participants	0 participants	0 participants
Erythema at Visit 3 (Week 3 - Pre Study Drug Application) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - pre-light)

Population: ITT, observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 3 (Week 3 - Pre-light) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants
Erythema at Visit 3 (Week 3 - Pre-light) Grade 0 (none)	27 participants	30 participants	27 participants	32 participants
Erythema at Visit 3 (Week 3 - Pre-light) Grade 1 (minimal)	24 participants	18 participants	27 participants	20 participants
Erythema at Visit 3 (Week 3 - Pre-light) Grade 2 (mild)	11 participants	12 participants	7 participants	12 participants
Erythema at Visit 3 (Week 3 - Pre-light) Grade 3 (moderate)	0 participants	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - post light treatment)

Population: ITT, observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 3 (Week 3 - Post Light Treatment) Grade 0 (none)	13 participants	16 participants	18 participants	21 participants
Erythema at Visit 3 (Week 3 - Post Light Treatment) Grade 1 (minimal)	28 participants	20 participants	30 participants	23 participants
Erythema at Visit 3 (Week 3 - Post Light Treatment) Grade 2 (mild)	17 participants	18 participants	13 participants	19 participants
Erythema at Visit 3 (Week 3 - Post Light Treatment) Grade 3 (moderate)	4 participants	6 participants	1 participants	2 participants
Erythema at Visit 3 (Week 3 - Post Light Treatment) Grade 4 (severe)	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6 - prior to study drug application)

Population: ITT, observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) Grade 0 (none)	36 participants	35 participants	31 participants	34 participants
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) Grade 1 (minimal)	20 participants	21 participants	22 participants	23 participants
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) Grade 2 (mild)	6 participants	7 participants	7 participants	6 participants
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) Grade 3 (moderate)	0 participants	0 participants	0 participants	0 participants
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Weeks 6 - pre-light treatment)

Population: ITT, observed

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 1000 Seconds n=58 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) Grade 0 (none)	27 participants	20 participants	22 participants	29 participants
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) Grade 1 (minimal)	22 participants	28 participants	29 participants	21 participants
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) Grade 2 (mild)	9 participants	12 participants	9 participants	11 participants
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) Grade 3 (moderate)	0 participants	1 participants	0 participants	1 participants
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6 - post light treatment)

Population: ITT, observed

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 1000 Seconds n=58 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 5 (Week 6 - Post Light Treatment) Grade 0 (none)	18 participants	13 participants	15 participants	19 participants
Erythema at Visit 5 (Week 6 - Post Light Treatment) Grade 1 (minimal)	16 participants	18 participants	28 participants	24 participants
Erythema at Visit 5 (Week 6 - Post Light Treatment) Grade 2 (mild)	19 participants	24 participants	15 participants	17 participants
Erythema at Visit 5 (Week 6 - Post Light Treatment) Grade 3 (moderate)	4 participants	6 participants	2 participants	2 participants
Erythema at Visit 5 (Week 6 - Post Light Treatment) Grade 4 (severe)	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - prior to study drug application)

Population: ITT observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) Grade 0 (none)	37 participants	34 participants	31 participants	36 participants
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) Grade 1 (minimal)	23 participants	22 participants	22 participants	25 participants
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) Grade 2 (mild)	3 participants	6 participants	4 participants	4 participants
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) Grade 3 (moderate)	0 participants	0 participants	0 participants	0 participants
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - pre light treatment)

Population: ITT observed

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 1000 Seconds n=56 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=60 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=56 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 7 (Week 9 - Pre Light Treatment) Grade 0 (none)	28 participants	26 participants	28 participants	33 participants
Erythema at Visit 7 (Week 9 - Pre Light Treatment) Grade 1 (minimal)	16 participants	24 participants	16 participants	21 participants
Erythema at Visit 7 (Week 9 - Pre Light Treatment) Grade 2 (mild)	11 participants	8 participants	11 participants	7 participants
Erythema at Visit 7 (Week 9 - Pre Light Treatment) Grade 3 (moderate)	1 participants	2 participants	1 participants	1 participants
Erythema at Visit 7 (Week 9 - Pre Light Treatment) Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - post light treatment)

Population: ITT, observed

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 1000 Seconds n=56 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=60 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=56 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema at Visit 7 (Week 9 - Post Light Treatment) Grade 0 (none)	20 participant	14 participant	20 participant	18 participant
Erythema at Visit 7 (Week 9 - Post Light Treatment) Grade 1 (minimal)	13 participant	18 participant	19 participant	23 participant
Erythema at Visit 7 (Week 9 - Post Light Treatment) Grade 2 (mild)	22 participant	21 participant	15 participant	19 participant
Erythema at Visit 7 (Week 9 - Post Light Treatment) Grade 3 (moderate)	1 participant	7 participant	2 participant	2 participant
Erythema at Visit 7 (Week 9 - Post Light Treatment) Grade 4 (severe)	0 participant	0 participant	0 participant	0 participant

SECONDARY outcome

Timeframe: 3 Weeks after Final PDT

Population: ITT observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema 3 Weeks After Final PDT Grade 0 (none)	36 participants	35 participants	32 participants	42 participants
Erythema 3 Weeks After Final PDT Grade 1 (minimal)	21 participants	18 participants	21 participants	16 participants
Erythema 3 Weeks After Final PDT Grade 2 (mild)	5 participants	8 participants	4 participants	5 participants
Erythema 3 Weeks After Final PDT Grade 3 (moderate)	0 participants	0 participants	0 participants	0 participants
Erythema 3 Weeks After Final PDT Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 Weeks after Final PDT

Population: ITT observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=64 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Erythema 6 Weeks After Final PDT Grade 0 (none)	39 participants	33 participants	30 participants	43 participants
Erythema 6 Weeks After Final PDT Grade 1 (minimal)	21 participants	20 participants	22 participants	20 participants
Erythema 6 Weeks After Final PDT Grade 2 (mild)	3 participants	9 participants	5 participants	1 participants
Erythema 6 Weeks After Final PDT Grade 3 (moderate)	0 participants	0 participants	0 participants	0 participants
Erythema 6 Weeks After Final PDT Grade 4 (severe)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline - pre light treatment

Population: ITT observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Baseline - Pre Light Treatment Grade 0 (none)	65 participants	63 participants	64 participants	65 participants
Edema at Baseline - Pre Light Treatment Grade 1 (minimal)	3 participants	2 participants	3 participants	1 participants
Edema at Baseline - Pre Light Treatment Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline - Post Light Treatment

Population: ITT observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=67 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Baseline - Post Light Treatment Grade 0 (none)	62 participants	63 participants	64 participants	65 participants
Edema at Baseline - Post Light Treatment Grade 1 (minimal)	5 participants	2 participants	3 participants	1 participants
Edema at Baseline - Post Light Treatment Grade 2 (mild)	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 48 hours after PDT #1

Population: ITT observed

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 1000 Seconds n=68 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=65 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema 48 Hours After PDT #1 Grade 0 (none)	64 participants	57 participants	61 participants	64 participants
Edema 48 Hours After PDT #1 Grade 2 (mild)	0 participants	1 participants	0 participants	0 participants
Edema 48 Hours After PDT #1 Grade 1 (minimal)	4 participants	7 participants	5 participants	2 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - before study drug application)

Population: ITT observed

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 1000 Seconds n=64 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=66 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 3 (Week 3 - Before Study Drug Application) Grade 1 (minimal)	2 participants	1 participants	1 participants	0 participants
Edema at Visit 3 (Week 3 - Before Study Drug Application) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants
Edema at Visit 3 (Week 3 - Before Study Drug Application) Grade 0 (none)	62 participants	61 participants	61 participants	66 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - before light treatment)

Population: ITT observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 3 (Week 3 - Before Light Treatment) Grade 0 (none)	60 participants	60 participants	61 participants	65 participants
Edema at Visit 3 (Week 3 - Before Light Treatment) Grade 1 (minimal)	2 participants	1 participants	1 participants	0 participants
Edema at Visit 3 (Week 3 - Before Light Treatment) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 3 (Week 3 - post light treatment)

Population: ITT observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 3 (Week 3 - Post Light Treatment) Grade 0 (none)	60 participants	59 participants	61 participants	64 participants
Edema at Visit 3 (Week 3 - Post Light Treatment) Grade 1 (minimal)	2 participants	2 participants	1 participants	1 participants
Edema at Visit 3 (Week 3 - Post Light Treatment) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6 - before study drug application)

Population: ITT observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 5 (Week 6 - Before Study Drug Application) Grade 1 (minimal)	2 participants	0 participants	1 participants	1 participants
Edema at Visit 5 (Week 6 - Before Study Drug Application) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants
Edema at Visit 5 (Week 6 - Before Study Drug Application) Grade 0 (none)	60 participants	63 participants	59 participants	62 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6 - pre light treatment)

Population: ITT observed

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 1000 Seconds n=58 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 5 (Week 6 - Pre Light Treatment) Grade 0 (none)	56 participants	61 participants	59 participants	61 participants
Edema at Visit 5 (Week 6 - Pre Light Treatment) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants
Edema at Visit 5 (Week 6 - Pre Light Treatment) Grade 1 (minimal)	2 participants	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Visit 5 (Week 6 - post light treatment)

Population: ITT observed

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 1000 Seconds n=58 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=60 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 5 (Week 6 - Post Light Treatment) Grade 0 (none)	55 participants	61 participants	57 participants	62 participants
Edema at Visit 5 (Week 6 - Post Light Treatment) Grade 1 (minimal)	3 participants	0 participants	3 participants	0 participants
Edema at Visit 5 (Week 6 - Post Light Treatment) Grade 2 (moderate)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - before study drug application)

Population: ITT observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=65 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 7 (Week 9 - Before Study Drug Application) Grade 1 (minimal)	3 participants	0 participants	1 participants	0 participants
Edema at Visit 7 (Week 9 - Before Study Drug Application) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants
Edema at Visit 7 (Week 9 - Before Study Drug Application) Grade 0 (none)	60 participants	62 participants	56 participants	65 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - prior to light treatment)

Population: ITT observed

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 1000 Seconds n=56 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=60 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=56 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 7 (Week 9 - Prior to Light Treatment) Grade 0 (none)	53 participants	59 participants	56 participants	62 participants
Edema at Visit 7 (Week 9 - Prior to Light Treatment) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants
Edema at Visit 7 (Week 9 - Prior to Light Treatment) Grade 1 (minimal)	3 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Visit 7 (Week 9 - post light treatment)

Population: ITT observed

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 1000 Seconds n=56 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=60 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=56 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=62 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema at Visit 7 (Week 9 - Post Light Treatment) Grade 0 (none)	53 participants	59 participants	55 participants	61 participants
Edema at Visit 7 (Week 9 - Post Light Treatment) Grade 1 (minimal)	3 participants	1 participants	1 participants	1 participants
Edema at Visit 7 (Week 9 - Post Light Treatment) Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 3 weeks after final PDT

Population: ITT observed

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 1000 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=61 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=63 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema 3 Weeks After Final PDT Grade 0 (none)	62 participants	60 participants	57 participants	63 participants
Edema 3 Weeks After Final PDT Grade 1 (minimal)	0 participants	1 participants	0 participants	0 participants
Edema 3 Weeks After Final PDT Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 weeks after final PDT

Population: ITT observed

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 1000 Seconds n=63 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	ALA 500 Seconds n=62 Participants Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)	Vehicle 1000 Seconds n=57 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)	Vehicle 500 Seconds n=64 Participants Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Edema 6 Weeks After Final PDT Grade 0 (none)	62 participants	62 participants	57 participants	64 participants
Edema 6 Weeks After Final PDT Grade 1 (minimal)	1 participants	0 participants	0 participants	0 participants
Edema 6 Weeks After Final PDT Grade 2 (mild)	0 participants	0 participants	0 participants	0 participants