Trial Outcomes & Findings for Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK) (NCT NCT01458587)
NCT ID: NCT01458587
Last Updated: 2013-03-14
Results Overview
Clearance rate for all lesions
COMPLETED
PHASE2
70 participants
Week 12
2013-03-14
Participant Flow
Recruitment period was from 28November2011 - 4April2012 at 3 medical clinics in the U.S.
Participant milestones
| Measure |
Aminolevulinic Acid
ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
Vehicle
Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Aminolevulinic Acid
ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
Vehicle
Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Baseline characteristics by cohort
| Measure |
Aminolevulinic Acid
n=35 Participants
ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
Vehicle
n=35 Participants
Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT analysis with LOCF
Clearance rate for all lesions
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Lesion Clearance Rate
|
88.7 percentage of lesions cleared
Standard Deviation 25.1
|
70.0 percentage of lesions cleared
Standard Deviation 31.1
|
16.7 percentage of lesions cleared
Standard Deviation 27.6
|
5.6 percentage of lesions cleared
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: Week 8Population: ITT LOCF
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Lesion Clearance Rate
|
75.0 percentage of lesions cleared
Standard Deviation 34.6
|
47.4 percentage of lesions cleared
Standard Deviation 30.7
|
3.3 percentage of lesions cleared
Standard Deviation 28.7
|
6.3 percentage of lesions cleared
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: Week 8Population: ITT LOCF
proportion of subjects with a count of zero lesions in the treatment area
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Complete Clearance Rate
|
8 arms 100% cleared
|
4 arms 100% cleared
|
0 arms 100% cleared
|
0 arms 100% cleared
|
SECONDARY outcome
Timeframe: Week 12Population: ITT LOCF
proportion of subjects with a count of zero lesions in the treatment area
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Complete Clearance Rate
|
12 arms 100% cleared
|
7 arms 100% cleared
|
0 arms 100% cleared
|
1 arms 100% cleared
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT LOCF
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Partial Clearance Rate
|
18 arms >75% cleared
|
5 arms >75% cleared
|
1 arms >75% cleared
|
2 arms >75% cleared
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT LOCF
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Partial Clearance Rate
|
21 arms >75% cleared
|
15 arms >75% cleared
|
3 arms >75% cleared
|
2 arms >75% cleared
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Outcome measures
| Measure |
ALA+OCC
n=35 arms
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 arms
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 arms
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 arms
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Subject Satisfaction Score
Slightly satisfied
|
3 participants
|
8 participants
|
7 participants
|
9 participants
|
|
Subject Satisfaction Score
Very satisfied
|
13 participants
|
7 participants
|
3 participants
|
1 participants
|
|
Subject Satisfaction Score
Moderately satisfied
|
16 participants
|
14 participants
|
5 participants
|
5 participants
|
|
Subject Satisfaction Score
Not satisfied
|
3 participants
|
6 participants
|
20 participants
|
20 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hyperpigmentation at Baseline
Grade 0 (none)
|
5 participants
|
5 participants
|
1 participants
|
1 participants
|
|
Hyperpigmentation at Baseline
Grade 1 (light)
|
20 participants
|
19 participants
|
23 participants
|
23 participants
|
|
Hyperpigmentation at Baseline
Grade 2 (moderate - small)
|
9 participants
|
10 participants
|
8 participants
|
8 participants
|
|
Hyperpigmentation at Baseline
Grade 3 (moderate - moderate)
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 2 weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=34 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hyperpigmentation at Visit 3
Grade 0 (none)
|
4 participants
|
4 participants
|
1 participants
|
1 participants
|
|
Hyperpigmentation at Visit 3
Grade 1 (light)
|
19 participants
|
20 participants
|
21 participants
|
21 participants
|
|
Hyperpigmentation at Visit 3
Grade 2 (moderate - small)
|
9 participants
|
10 participants
|
10 participants
|
10 participants
|
|
Hyperpigmentation at Visit 3
Grade 3 (moderate - moderate)
|
2 participants
|
1 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 8 weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hyperpigmentation at Visit 4
Grade 0 (none)
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Hyperpigmentation at Visit 4
Grade 1 (light)
|
24 participants
|
21 participants
|
19 participants
|
17 participants
|
|
Hyperpigmentation at Visit 4
Grade 2 (moderate - small)
|
8 participants
|
11 participants
|
11 participants
|
13 participants
|
|
Hyperpigmentation at Visit 4
Grade 3 (moderate - moderate)
|
1 participants
|
1 participants
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 12 weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hyperpigmentation at Visit 5
Grade 0 (none)
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Hyperpigmentation at Visit 5
Grade 1 (light)
|
25 participants
|
23 participants
|
20 participants
|
20 participants
|
|
Hyperpigmentation at Visit 5
Grade 2 (moderate - small)
|
6 participants
|
8 participants
|
11 participants
|
11 participants
|
|
Hyperpigmentation at Visit 5
Grade 3 (moderate - moderate)
|
0 participants
|
0 participants
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hypopigmentation at Baseline
Grade 0 (none)
|
9 participants
|
9 participants
|
8 participants
|
8 participants
|
|
Hypopigmentation at Baseline
Grade 1 (light)
|
21 participants
|
21 participants
|
24 participants
|
24 participants
|
|
Hypopigmentation at Baseline
Grade 2 (moderate - small)
|
5 participants
|
5 participants
|
2 participants
|
2 participants
|
|
Hypopigmentation at Baseline
Grade 3 (moderate - moderate)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=34 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hypopigmentation at Visit 3
Grade 0 (none)
|
10 participants
|
10 participants
|
7 participants
|
7 participants
|
|
Hypopigmentation at Visit 3
Grade 1 (light)
|
20 participants
|
20 participants
|
26 participants
|
26 participants
|
|
Hypopigmentation at Visit 3
Grade 2 (moderate - small)
|
4 participants
|
5 participants
|
1 participants
|
1 participants
|
|
Hypopigmentation at Visit 3
Grade 3 (moderate - moderate)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hypopigmentation at Visit 4
Grade 0 (none)
|
13 participants
|
10 participants
|
9 participants
|
9 participants
|
|
Hypopigmentation at Visit 4
Grade 1 (light)
|
18 participants
|
21 participants
|
23 participants
|
23 participants
|
|
Hypopigmentation at Visit 4
Grade 2 (moderate - small)
|
3 participants
|
4 participants
|
1 participants
|
1 participants
|
|
Hypopigmentation at Visit 4
Grade 3 (moderate - moderate)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Hypopigmentation at Visit 5
Grade 0 (none)
|
10 participants
|
8 participants
|
12 participants
|
11 participants
|
|
Hypopigmentation at Visit 5
Grade 1 (light)
|
22 participants
|
24 participants
|
21 participants
|
22 participants
|
|
Hypopigmentation at Visit 5
Grade 2 (moderate - small)
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Hypopigmentation at Visit 5
Grade 3 (moderate - moderate)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Erythema at Baseline
Grade 1 (minimal)
|
16 participants
|
16 participants
|
13 participants
|
12 participants
|
|
Erythema at Baseline
Grade 2 (mild)
|
8 participants
|
9 participants
|
9 participants
|
10 participants
|
|
Erythema at Baseline
Grade 3 (moderate)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Erythema at Baseline
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Erythema at Baseline
Grade 0 (none)
|
10 participants
|
10 participants
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 5 Minutes after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Erythema Post-Light Treatment
Grade 0 (none)
|
0 participants
|
0 participants
|
4 participants
|
4 participants
|
|
Erythema Post-Light Treatment
Grade 1 (minimal)
|
0 participants
|
4 participants
|
11 participants
|
15 participants
|
|
Erythema Post-Light Treatment
Grade 2 (mild)
|
7 participants
|
19 participants
|
17 participants
|
13 participants
|
|
Erythema Post-Light Treatment
Grade 3 (moderate)
|
21 participants
|
10 participants
|
3 participants
|
3 participants
|
|
Erythema Post-Light Treatment
Grade 4 (severe)
|
7 participants
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Erythema at Visit 3
Grade 0 (none)
|
0 participants
|
4 participants
|
10 participants
|
10 participants
|
|
Erythema at Visit 3
Grade 1 (minimal)
|
8 participants
|
14 participants
|
15 participants
|
14 participants
|
|
Erythema at Visit 3
Grade 2 (mild)
|
14 participants
|
15 participants
|
9 participants
|
10 participants
|
|
Erythema at Visit 3
Grade 3 (moderate)
|
12 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Erythema at Visit 3
Grade 4 (severe)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Erythema at Visit 4
Grade 0 (none)
|
7 participants
|
6 participants
|
10 participants
|
11 participants
|
|
Erythema at Visit 4
Grade 1 (minimal)
|
17 participants
|
20 participants
|
16 participants
|
15 participants
|
|
Erythema at Visit 4
Grade 2 (mild)
|
9 participants
|
9 participants
|
7 participants
|
7 participants
|
|
Erythema at Visit 4
Grade 3 (moderate)
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Erythema at Visit 4
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Erythema at Visit 5
Grade 0 (none)
|
9 participants
|
7 participants
|
11 participants
|
12 participants
|
|
Erythema at Visit 5
Grade 1 (minimal)
|
7 participants
|
12 participants
|
14 participants
|
14 participants
|
|
Erythema at Visit 5
Grade 2 (mild)
|
16 participants
|
14 participants
|
10 participants
|
9 participants
|
|
Erythema at Visit 5
Grade 3 (moderate)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Erythema at Visit 5
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Edema at Baseline
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Baseline
Grade 0 (none)
|
35 participants
|
35 participants
|
35 participants
|
35 participants
|
|
Edema at Baseline
Grade 1 (minimal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 Minutes after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Edema Post-Light Treatment
Grade 0 (none)
|
28 participants
|
33 participants
|
34 participants
|
34 participants
|
|
Edema Post-Light Treatment
Grade 1 (minimal)
|
5 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Edema Post-Light Treatment
Grade 2 (mild)
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Edema at Visit 3
Grade 0 (none)
|
27 participants
|
34 participants
|
35 participants
|
35 participants
|
|
Edema at Visit 3
Grade 1 (minimal)
|
5 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 3
Grade 2 (mild)
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Edema at Visit 4
Grade 0 (none)
|
35 participants
|
35 participants
|
34 participants
|
34 participants
|
|
Edema at Visit 4
Grade 1 (minimal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 4
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Edema at Visit 5
Grade 0 (none)
|
33 participants
|
33 participants
|
35 participants
|
35 participants
|
|
Edema at Visit 5
Grade 1 (minimal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 5
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT, observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning at Baseline
Grade 0 (none)
|
35 participants
|
35 participants
|
35 participants
|
35 participants
|
|
Stinging/Burning at Baseline
Grade 1 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Baseline
Grade 2 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Baseline
Grade 3 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During PDT #1Population: ITT, observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning During Light Treatment
Grade 0 (none)
|
0 participants
|
0 participants
|
29 participants
|
29 participants
|
|
Stinging/Burning During Light Treatment
Grade 1 (mild)
|
5 participants
|
20 participants
|
6 participants
|
6 participants
|
|
Stinging/Burning During Light Treatment
Grade 2 (moderate)
|
21 participants
|
12 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning During Light Treatment
Grade 3 (severe)
|
9 participants
|
3 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 minutes after PDT #1Population: ITT, observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning Post Light Treatment
Grade 0 (none)
|
0 participants
|
2 participants
|
30 participants
|
33 participants
|
|
Stinging/Burning Post Light Treatment
Grade 1 (mild)
|
7 participants
|
22 participants
|
5 participants
|
2 participants
|
|
Stinging/Burning Post Light Treatment
Grade 2 (moderate)
|
21 participants
|
10 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning Post Light Treatment
Grade 3 (severe)
|
7 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 Weeks after PDT #1Population: ITT, observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning at Visit 3
Grade 0 (none)
|
31 participants
|
35 participants
|
35 participants
|
35 participants
|
|
Stinging/Burning at Visit 3
Grade 1 (mild)
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 3
Grade 2 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 3
Grade 3 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 Weeks after PDT #1Population: ITT, observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning at Visit 4
Grade 0 (none)
|
35 participants
|
35 participants
|
34 participants
|
34 participants
|
|
Stinging/Burning at Visit 4
Grade 1 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 4
Grade 2 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 4
Grade 3 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 Weeks after PDT #1Population: ITT, observed
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Stinging/Burning at Visit 5
Grade 3 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 5
Grade 0 (none)
|
33 participants
|
33 participants
|
35 participants
|
35 participants
|
|
Stinging/Burning at Visit 5
Grade 1 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 5
Grade 2 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Scaling and Dryness at Baseline
Grade 0 (none)
|
16 participants
|
16 participants
|
17 participants
|
17 participants
|
|
Scaling and Dryness at Baseline
Grade 1 (minimal)
|
15 participants
|
15 participants
|
13 participants
|
13 participants
|
|
Scaling and Dryness at Baseline
Grade 2 (mild)
|
2 participants
|
2 participants
|
4 participants
|
4 participants
|
|
Scaling and Dryness at Baseline
Grade 3 (moderate)
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Scaling and Dryness at Baseline
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 Weeks Post PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Scaling and Dryness at Visit 3
Grade 0 (none)
|
3 participants
|
5 participants
|
10 participants
|
11 participants
|
|
Scaling and Dryness at Visit 3
Grade 1 (minimal)
|
5 participants
|
17 participants
|
20 participants
|
19 participants
|
|
Scaling and Dryness at Visit 3
Grade 2 (mild)
|
5 participants
|
10 participants
|
3 participants
|
3 participants
|
|
Scaling and Dryness at Visit 3
Grade 3 (moderate)
|
21 participants
|
3 participants
|
2 participants
|
2 participants
|
|
Scaling and Dryness at Visit 3
Grade 4 (severe)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 Weeks Post PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Scaling and Dryness at Visit 4
Grade 0 (none)
|
16 participants
|
17 participants
|
14 participants
|
14 participants
|
|
Scaling and Dryness at Visit 4
Grade 1 (minimal)
|
14 participants
|
12 participants
|
14 participants
|
14 participants
|
|
Scaling and Dryness at Visit 4
Grade 2 (mild)
|
4 participants
|
5 participants
|
3 participants
|
3 participants
|
|
Scaling and Dryness at Visit 4
Grade 3 (moderate)
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
|
Scaling and Dryness at Visit 4
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 Weeks Post PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
Scaling and Dryness at Visit 5
Grade 2 (mild)
|
2 participants
|
2 participants
|
5 participants
|
5 participants
|
|
Scaling and Dryness at Visit 5
Grade 0 (none)
|
18 participants
|
17 participants
|
12 participants
|
12 participants
|
|
Scaling and Dryness at Visit 5
Grade 1 (minimal)
|
12 participants
|
13 participants
|
17 participants
|
17 participants
|
|
Scaling and Dryness at Visit 5
Grade 3 (moderate)
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Scaling and Dryness at Visit 5
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
OOZING/VESICULATION/CRUSTING at Baseline
Grade 0 (none)
|
35 participants
|
35 participants
|
35 participants
|
35 participants
|
|
OOZING/VESICULATION/CRUSTING at Baseline
Grade 1 (minimal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Baseline
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Baseline
Grade 3 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Baseline
Grade 4 (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 2 after PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
OOZING/VESICULATION/CRUSTING at Visit 3
Grade 0 (none)
|
33 participants
|
34 participants
|
34 participants
|
34 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 3
Grade 1 (minimal)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 3
Grade 2 (mild)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 3
Grade 3 (moderate)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 3
0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 Weeks after PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=35 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=35 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=34 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=34 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
OOZING/VESICULATION/CRUSTING at Visit 4
Grade 0 (none)
|
35 participants
|
35 participants
|
34 participants
|
34 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 4
Grade 1 (minimal)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 4
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 4
Grade 3 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 4
0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 Weeks after PDT #1Population: ITT observed
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
| Measure |
ALA+OCC
n=33 Participants
ALA application on one extremity occluded with plastic wrap during the incubation period.
|
ALA-OCC
n=33 Participants
ALA application on one extremity unoccluded during the incubation period.
|
VEH+OCC
n=35 Participants
Vehicle application on one extremity occluded with plastic wrap during the incubation period.
|
VEH-OCC
n=35 Participants
Vehicle application on one extremity unoccluded during the incubation period.
|
|---|---|---|---|---|
|
OOZING/VESICULATION/CRUSTING at Visit 5
Grade 0 (none)
|
33 participants
|
32 participants
|
35 participants
|
35 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 5
Grade 1 (minimal)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 5
Grade 2 (mild)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 5
Grade 3 (moderate)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
OOZING/VESICULATION/CRUSTING at Visit 5
0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Aminolevulinic Acid
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aminolevulinic Acid
n=35 participants at risk
ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
Vehicle
n=35 participants at risk
Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/35
|
5.7%
2/35 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
11.4%
4/35 • Number of events 5
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/35
|
5.7%
2/35 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain
|
25.7%
9/35 • Number of events 10
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
|
Skin and subcutaneous tissue disorders
Swelling
|
5.7%
2/35 • Number of events 2
|
0.00%
0/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication of results from multi-center trial will be made by the Sponsor. If publication is not submitted within 12 months after conclusion of the study, 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 60 days before publication so that sponsor can review the publication for confidential information.
- Publication restrictions are in place
Restriction type: OTHER