Trial Outcomes & Findings for Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK) (NCT NCT01475955)
NCT ID: NCT01475955
Last Updated: 2016-10-28
Results Overview
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
235 participants
Primary outcome timeframe
Week 12
Results posted on
2016-10-28
Participant Flow
Participant milestones
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
|
Broad Area ALA 2-hour + BLUE Light Treatment
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.
Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
47
|
46
|
46
|
|
Overall Study
COMPLETED
|
47
|
48
|
44
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
Baseline characteristics by cohort
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
|
Vehicle (VEH) + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.0 • n=93 Participants
|
67.1 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
66.4 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
69.5 years
STANDARD_DEVIATION 9.7 • n=483 Participants
|
68.4 years
STANDARD_DEVIATION 9.4 • n=36 Participants
|
67.5 years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
212 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=93 Participants
|
48 participants
n=4 Participants
|
47 participants
n=27 Participants
|
46 participants
n=483 Participants
|
46 participants
n=36 Participants
|
235 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Complete Clearance Rate
|
14 participants
|
7 participants
|
13 participants
|
8 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT LOCF
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Complete Clearance Rate
|
5 participants
|
8 participants
|
5 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Complete Clearance Rate
|
3 participants
|
7 participants
|
8 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Complete Clearance Rate
|
11 participants
|
3 participants
|
12 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Partial Clearance Rate
|
12 participants
|
16 participants
|
14 participants
|
12 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Partial Clearance Rate
|
10 participants
|
13 participants
|
15 participants
|
13 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Partial Clearance Rate
|
23 participants
|
24 participants
|
25 participants
|
20 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline Week 24proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Partial Clearance Rate
|
18 participants
|
19 participants
|
24 participants
|
17 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
AK Clearance Rate
|
40 percent clearance
Standard Deviation 41.8
|
58.4 percent clearance
Standard Deviation 34.8
|
54.5 percent clearance
Standard Deviation 30.4
|
56.3 percent clearance
Standard Deviation 54.3
|
0.0 percent clearance
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: Baseline, Week 8AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
AK Clearance Rate
|
35.7 percent clearance
Standard Deviation 42.0
|
52.5 percent clearance
Standard Deviation 37.2
|
57.1 percent clearance
Standard Deviation 37.0
|
57.1 percent clearance
Standard Deviation 43.8
|
5.7 percent clearance
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
AK Clearance Rate
|
71.4 percent clearance
Standard Deviation 34.8
|
73.6 percent clearance
Standard Deviation 31.1
|
78.6 percent clearance
Standard Deviation 30.5
|
68.3 percent clearance
Standard Deviation 39.4
|
7.1 percent clearance
Standard Deviation 44.3
|
SECONDARY outcome
Timeframe: Baseline, Week 24AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
AK Clearance Rate
|
66.7 percent clearance
Standard Deviation 43.4
|
64.9 percent clearance
Standard Deviation 36.3
|
75.0 percent clearance
Standard Deviation 46.3
|
63.4 percent clearance
Standard Deviation 44.3
|
14.3 percent clearance
Standard Deviation 44.0
|
SECONDARY outcome
Timeframe: Week 240 = no improvement or worsening (not satisfied at all) 1. = slight improvement (slightly satisfied) 2. = moderate improvement (moderately satisfied) 3. = excellent improvement (very satisfied)
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Subject Satisfaction Score
0 = no improvement or worsening (not satisfied at
|
7 participants
|
2 participants
|
4 participants
|
7 participants
|
24 participants
|
|
Subject Satisfaction Score
3 = excellent improvement (very satisfied)
|
20 participants
|
21 participants
|
20 participants
|
20 participants
|
7 participants
|
|
Subject Satisfaction Score
2 = moderate improvement (moderately satisfied)
|
14 participants
|
16 participants
|
19 participants
|
17 participants
|
9 participants
|
|
Subject Satisfaction Score
1 = slight improvement (slightly satisfied)
|
6 participants
|
9 participants
|
1 participants
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: BaselineHYPERPIGMENTATION 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Baseline
Grade 1 - Light
|
23 participants
|
24 participants
|
23 participants
|
21 participants
|
27 participants
|
|
Hyperpigmentation at Baseline
Grade 3 - Moderate/moderate
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Hyperpigmentation at Baseline
Grade 0 - None
|
12 participants
|
8 participants
|
17 participants
|
14 participants
|
11 participants
|
|
Hyperpigmentation at Baseline
Grade 2 - Moderate/small
|
12 participants
|
14 participants
|
6 participants
|
9 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 24-48 Hours after PDT #1HYPERPIGMENTATION 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 2
Grade 2 - Moderate/small
|
9 participants
|
11 participants
|
5 participants
|
11 participants
|
4 participants
|
|
Hyperpigmentation at Visit 2
Grade 0 - None
|
17 participants
|
12 participants
|
18 participants
|
15 participants
|
16 participants
|
|
Hyperpigmentation at Visit 2
Grade 1 - Light
|
19 participants
|
24 participants
|
23 participants
|
19 participants
|
25 participants
|
|
Hyperpigmentation at Visit 2
Grade 3 - Moderate/moderate
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 2HYPERPIGMENTATION 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 3
Grade 0 - None
|
16 participants
|
10 participants
|
20 participants
|
16 participants
|
15 participants
|
|
Hyperpigmentation at Visit 3
Grade 2 - Moderate/small
|
12 participants
|
10 participants
|
5 participants
|
7 participants
|
4 participants
|
|
Hyperpigmentation at Visit 3
Grade 3 - Moderate/moderate
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Hyperpigmentation at Visit 3
Grade 1 - Light
|
18 participants
|
27 participants
|
21 participants
|
23 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 4
Grade 0 - None
|
16 participants
|
11 participants
|
22 participants
|
16 participants
|
12 participants
|
|
Hyperpigmentation at Visit 4
Grade 3 - Moderate/moderate
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Hyperpigmentation at Visit 4
Grade 1 - Light
|
21 participants
|
25 participants
|
15 participants
|
21 participants
|
25 participants
|
|
Hyperpigmentation at Visit 4
Grade 2 - Moderate/small
|
10 participants
|
11 participants
|
6 participants
|
9 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 5
Grade 0 - None
|
16 participants
|
11 participants
|
17 participants
|
14 participants
|
11 participants
|
|
Hyperpigmentation at Visit 5
Grade 2 - Moderate/small
|
12 participants
|
10 participants
|
7 participants
|
8 participants
|
6 participants
|
|
Hyperpigmentation at Visit 5
Grade 3 - Moderate/moderate
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Hyperpigmentation at Visit 5
Grade 1 - Light
|
19 participants
|
26 participants
|
20 participants
|
23 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 6
Grade 0 - None
|
17 participants
|
9 participants
|
18 participants
|
17 participants
|
11 participants
|
|
Hyperpigmentation at Visit 6
Grade 1 - Light
|
18 participants
|
29 participants
|
16 participants
|
20 participants
|
24 participants
|
|
Hyperpigmentation at Visit 6
Grade 2 - Moderate/small
|
11 participants
|
8 participants
|
9 participants
|
8 participants
|
8 participants
|
|
Hyperpigmentation at Visit 6
Grade 3 - Moderate/moderate
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hyperpigmentation at Visit 7
Grade 2 - Moderate/small
|
7 participants
|
10 participants
|
4 participants
|
6 participants
|
7 participants
|
|
Hyperpigmentation at Visit 7
Grade 0 - None
|
16 participants
|
9 participants
|
20 participants
|
18 participants
|
13 participants
|
|
Hyperpigmentation at Visit 7
Grade 1 - Light
|
23 participants
|
27 participants
|
19 participants
|
21 participants
|
25 participants
|
|
Hyperpigmentation at Visit 7
Grade 3 - Moderate/moderate
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Hyperpigmentation at Visit 7
Grade 4 - Marked
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineHYPOPIGMENTATION 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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Baseline
Grade 0 - None
|
21 participants
|
20 participants
|
30 participants
|
22 participants
|
18 participants
|
|
Hypopigmentation at Baseline
Grade 1 - Light
|
21 participants
|
25 participants
|
16 participants
|
23 participants
|
24 participants
|
|
Hypopigmentation at Baseline
Grade 2 - Moderate/small
|
5 participants
|
3 participants
|
1 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 24-48 Hours after PDT #1HYPOPIGMENTATION 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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 2
Grade 1 - Light
|
16 participants
|
20 participants
|
14 participants
|
22 participants
|
20 participants
|
|
Hypopigmentation at Visit 2
Grade 0 - None
|
25 participants
|
24 participants
|
31 participants
|
23 participants
|
23 participants
|
|
Hypopigmentation at Visit 2
Grade 2 - Moderate/small
|
6 participants
|
4 participants
|
2 participants
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 3
Grade 0 - None
|
25 participants
|
23 participants
|
31 participants
|
21 participants
|
20 participants
|
|
Hypopigmentation at Visit 3
Grade 1 - Light
|
17 participants
|
22 participants
|
14 participants
|
24 participants
|
21 participants
|
|
Hypopigmentation at Visit 3
Grade 2 - Moderate/small
|
5 participants
|
3 participants
|
2 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 4
Grade - None
|
25 participants
|
20 participants
|
29 participants
|
19 participants
|
19 participants
|
|
Hypopigmentation at Visit 4
Grade 2 - Moderate/small
|
5 participants
|
1 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Hypopigmentation at Visit 4
Grade 1 - Light
|
17 participants
|
21 participants
|
16 participants
|
26 participants
|
22 participants
|
|
Hypopigmentation at Visit 4
Grade 3 - Moderate/moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 5
Grade 1 - Light
|
21 participants
|
26 participants
|
17 participants
|
25 participants
|
23 participants
|
|
Hypopigmentation at Visit 5
Grade 0 - None
|
23 participants
|
19 participants
|
28 participants
|
17 participants
|
18 participants
|
|
Hypopigmentation at Visit 5
Grade 2 - Moderate/small
|
3 participants
|
3 participants
|
0 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 6
Grade 0 - None
|
23 participants
|
20 participants
|
26 participants
|
19 participants
|
15 participants
|
|
Hypopigmentation at Visit 6
Grade 1 - Light
|
21 participants
|
26 participants
|
18 participants
|
20 participants
|
26 participants
|
|
Hypopigmentation at Visit 6
Grade 2 - Moderate/small
|
3 participants
|
2 participants
|
0 participants
|
6 participants
|
3 participants
|
|
Hypopigmentation at Visit 6
Grade 3 - Moderate/moderate
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Hypopigmentation at Visit 7
Grade 0 - None
|
22 participants
|
18 participants
|
28 participants
|
20 participants
|
17 participants
|
|
Hypopigmentation at Visit 7
Grade 1 - Light
|
22 participants
|
27 participants
|
15 participants
|
24 participants
|
25 participants
|
|
Hypopigmentation at Visit 7
Grade 2 - Moderate/small
|
3 participants
|
3 participants
|
1 participants
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: BaselineErythema 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Baseline
Grade 1 - Minimal
|
23 participants
|
23 participants
|
24 participants
|
19 participants
|
18 participants
|
|
Erythema at Baseline
Grade 0 - None
|
14 participants
|
10 participants
|
15 participants
|
19 participants
|
15 participants
|
|
Erythema at Baseline
Grade 2 Mild
|
10 participants
|
15 participants
|
8 participants
|
8 participants
|
11 participants
|
|
Erythema at Baseline
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 5 minutes after PDT #1Erythema 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema Post-Light Treatment
Grade 0 - None
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Erythema Post-Light Treatment
Grade 1 - Minimal
|
8 participants
|
4 participants
|
5 participants
|
9 participants
|
25 participants
|
|
Erythema Post-Light Treatment
Grade 2 Mild
|
19 participants
|
16 participants
|
13 participants
|
18 participants
|
14 participants
|
|
Erythema Post-Light Treatment
Grade 3 - Moderate
|
16 participants
|
26 participants
|
22 participants
|
18 participants
|
3 participants
|
|
Erythema Post-Light Treatment
Grade 4 - Severe
|
2 participants
|
2 participants
|
7 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24-48 hours after PDT #1Erythema 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 2
Grade 4 - Severe
|
2 participants
|
8 participants
|
12 participants
|
2 participants
|
0 participants
|
|
Erythema at Visit 2
Grade 0 - None
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
13 participants
|
|
Erythema at Visit 2
Grade 1 - Minimal
|
8 participants
|
3 participants
|
4 participants
|
11 participants
|
17 participants
|
|
Erythema at Visit 2
Grade 2 Mild
|
10 participants
|
14 participants
|
12 participants
|
9 participants
|
14 participants
|
|
Erythema at Visit 2
Grade 3 - Moderate
|
25 participants
|
23 participants
|
18 participants
|
24 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 3
Grade 1 - Minimal
|
22 participants
|
23 participants
|
19 participants
|
26 participants
|
21 participants
|
|
Erythema at Visit 3
Grade 3 - Moderate
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Erythema at Visit 3
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Erythema at Visit 3
Grade 0 - None
|
11 participants
|
5 participants
|
11 participants
|
14 participants
|
15 participants
|
|
Erythema at Visit 3
Grade 2 Mild
|
13 participants
|
18 participants
|
14 participants
|
6 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 4
Grade 0 - None
|
12 participants
|
13 participants
|
16 participants
|
12 participants
|
14 participants
|
|
Erythema at Visit 4
Grade 1 - Minimal
|
27 participants
|
22 participants
|
20 participants
|
26 participants
|
18 participants
|
|
Erythema at Visit 4
Grade 2 Mild
|
8 participants
|
13 participants
|
9 participants
|
7 participants
|
12 participants
|
|
Erythema at Visit 4
Grade 3 - Moderate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Erythema at Visit 4
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8 pre-drugPopulation: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 5 (Pre-drug)
Grade 1 - Minimal
|
25 participants
|
17 participants
|
22 participants
|
19 participants
|
20 participants
|
|
Erythema at Visit 5 (Pre-drug)
Grade 2 Mild
|
9 participants
|
16 participants
|
5 participants
|
6 participants
|
10 participants
|
|
Erythema at Visit 5 (Pre-drug)
Grade 0 - None
|
13 participants
|
15 participants
|
17 participants
|
21 participants
|
12 participants
|
|
Erythema at Visit 5 (Pre-drug)
Grade 3 - Moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Erythema at Visit 5 (Pre-drug)
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8 5 minutes post light treatmentPopulation: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=41 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=37 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=31 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=41 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 5 (Post-light)
Grade 0 - None
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
|
Erythema at Visit 5 (Post-light)
Grade 1 - Minimal
|
8 participants
|
5 participants
|
7 participants
|
9 participants
|
28 participants
|
|
Erythema at Visit 5 (Post-light)
Grade 2 Mild
|
19 participants
|
10 participants
|
7 participants
|
19 participants
|
7 participants
|
|
Erythema at Visit 5 (Post-light)
Grade 3 - Moderate
|
12 participants
|
19 participants
|
16 participants
|
13 participants
|
5 participants
|
|
Erythema at Visit 5 (Post-light)
Grade 4 - Severe
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 6
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Erythema at Visit 6
Grade 0 - None
|
16 participants
|
15 participants
|
18 participants
|
22 participants
|
17 participants
|
|
Erythema at Visit 6
Grade 1 - Minimal
|
24 participants
|
23 participants
|
19 participants
|
19 participants
|
18 participants
|
|
Erythema at Visit 6
Grade 2 Mild
|
7 participants
|
10 participants
|
7 participants
|
4 participants
|
8 participants
|
|
Erythema at Visit 6
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Erythema at Visit 7
Grade 0 - None
|
20 participants
|
16 participants
|
19 participants
|
27 participants
|
21 participants
|
|
Erythema at Visit 7
Grade 1 - Minimal
|
19 participants
|
20 participants
|
20 participants
|
15 participants
|
16 participants
|
|
Erythema at Visit 7
Grade 2 Mild
|
7 participants
|
12 participants
|
5 participants
|
4 participants
|
7 participants
|
|
Erythema at Visit 7
Grade 3 - Moderate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Erythema at Visit 7
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineEDEMA 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Baseline
Grade 0 - None
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Edema at Baseline
Grade 1 - Minimal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Baseline
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Baseline
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Baseline
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 minutes after PDT #1EDEMA 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema Post-Light Treatment
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema Post-Light Treatment
Grade 0 - None
|
37 participants
|
28 participants
|
27 participants
|
33 participants
|
44 participants
|
|
Edema Post-Light Treatment
Grade 1 - Minimal
|
8 participants
|
12 participants
|
11 participants
|
10 participants
|
2 participants
|
|
Edema Post-Light Treatment
Grade 2 - Mild
|
2 participants
|
7 participants
|
3 participants
|
3 participants
|
0 participants
|
|
Edema Post-Light Treatment
Grade 3 - Moderate
|
0 participants
|
1 participants
|
6 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24-48 hours post PDT#1EDEMA 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Visit 2
Grade 0 - None
|
32 participants
|
31 participants
|
26 participants
|
27 participants
|
44 participants
|
|
Edema at Visit 2
Grade 1 - Minimal
|
8 participants
|
10 participants
|
10 participants
|
13 participants
|
2 participants
|
|
Edema at Visit 2
Grade 2 - Mild
|
5 participants
|
3 participants
|
6 participants
|
4 participants
|
0 participants
|
|
Edema at Visit 2
Grade 3 - Moderate
|
2 participants
|
3 participants
|
4 participants
|
2 participants
|
0 participants
|
|
Edema at Visit 2
Grade 4 - Severe
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Visit 3
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 3
Grade 0 - None
|
46 participants
|
44 participants
|
42 participants
|
44 participants
|
44 participants
|
|
Edema at Visit 3
Grade 1 - Minimal
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Edema at Visit 3
Grade 2 - Mild
|
0 participants
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 3
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Visit 4
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 4
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 4
Grade 0 - None
|
46 participants
|
47 participants
|
46 participants
|
46 participants
|
45 participants
|
|
Edema at Visit 4
Grade 1 - Minimal
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 4
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8 pre-drugPopulation: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Visit 5 (Pre-drug)
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 5 (Pre-drug)
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 5 (Pre-drug)
Grade 0 - None
|
47 participants
|
48 participants
|
45 participants
|
46 participants
|
44 participants
|
|
Edema at Visit 5 (Pre-drug)
Grade 1 - Minimal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Visit 5 (Pre-drug)
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 minutes post PDT #2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=41 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=37 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=31 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=41 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema Post PDT #2
Grade 1 - Minimal
|
6 participants
|
12 participants
|
7 participants
|
11 participants
|
1 participants
|
|
Edema Post PDT #2
Grade 0 - None
|
32 participants
|
20 participants
|
18 participants
|
26 participants
|
43 participants
|
|
Edema Post PDT #2
Grade 2 - Mild
|
2 participants
|
4 participants
|
3 participants
|
4 participants
|
0 participants
|
|
Edema Post PDT #2
Grade 3 - Moderate
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Edema Post PDT #2
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Week 12
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Week 12
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Week 12
Grade 0 - None
|
47 participants
|
48 participants
|
43 participants
|
46 participants
|
44 participants
|
|
Edema at Week 12
Grade 1 - Minimal
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Edema at Week 12
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Edema at Week 24
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Week 24
Grade 0 - None
|
47 participants
|
48 participants
|
43 participants
|
45 participants
|
45 participants
|
|
Edema at Week 24
Grade 1 - Minimal
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Edema at Week 24
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Edema at Week 24
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSTINGING 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Baseline
Grade 2 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Baseline
Grade 0 - None
|
47 participants
|
48 participants
|
47 participants
|
46 participants
|
44 participants
|
|
Stinging/Burning at Baseline
Grade 1 - MInimal
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Stinging/Burning at Baseline
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During PDT #1 (most intense sensation)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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning During Light Treatment
Grade 0 - None
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
35 participants
|
|
Stinging/Burning During Light Treatment
Grade 2 - Moderate
|
23 participants
|
29 participants
|
22 participants
|
19 participants
|
6 participants
|
|
Stinging/Burning During Light Treatment
Grade 1 - MInimal
|
15 participants
|
9 participants
|
10 participants
|
16 participants
|
11 participants
|
|
Stinging/Burning During Light Treatment
Grade 3 - Severe
|
7 participants
|
9 participants
|
15 participants
|
8 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 minutes post PDT #1STINGING 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning Post Light-Treatment
Grade 2 - Moderate
|
8 participants
|
25 participants
|
19 participants
|
13 participants
|
0 participants
|
|
Stinging/Burning Post Light-Treatment
Grade 3 - Severe
|
2 participants
|
1 participants
|
8 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning Post Light-Treatment
Grade 0 - None
|
8 participants
|
5 participants
|
1 participants
|
8 participants
|
40 participants
|
|
Stinging/Burning Post Light-Treatment
Grade 1 - MInimal
|
29 participants
|
17 participants
|
19 participants
|
25 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 24-48 hours post PDT #1STINGING 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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 2
Grade 0 - None
|
25 participants
|
23 participants
|
20 participants
|
35 participants
|
41 participants
|
|
Stinging/Burning at Visit 2
Grade 3 - Severe
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 2
Grade 1 - MInimal
|
18 participants
|
20 participants
|
17 participants
|
10 participants
|
4 participants
|
|
Stinging/Burning at Visit 2
Grade 2 - Moderate
|
4 participants
|
4 participants
|
7 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 3
Grade 0 - None
|
46 participants
|
45 participants
|
44 participants
|
46 participants
|
45 participants
|
|
Stinging/Burning at Visit 3
Grade 2 - Moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 3
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 3
Grade 1 - MInimal
|
1 participants
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 4
Grade 1 - MInimal
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 4
Grade 2 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Stinging/Burning at Visit 4
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 4
Grade 0 - None
|
45 participants
|
47 participants
|
46 participants
|
46 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Week 8 prior to drugPopulation: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 5 (Pre-drug)
Grade 0 - None
|
47 participants
|
48 participants
|
45 participants
|
45 participants
|
42 participants
|
|
Stinging/Burning at Visit 5 (Pre-drug)
Grade 1 - MInimal
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Stinging/Burning at Visit 5 (Pre-drug)
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 5 (Pre-drug)
Grade 2 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: during PDT #2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=41 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=37 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=31 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=41 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 5 During PDT#2
Grade 0 - None
|
4 participants
|
1 participants
|
0 participants
|
4 participants
|
28 participants
|
|
Stinging/Burning at Visit 5 During PDT#2
Grade 1 - MInimal
|
20 participants
|
11 participants
|
7 participants
|
23 participants
|
16 participants
|
|
Stinging/Burning at Visit 5 During PDT#2
Grade 2 - Moderate
|
15 participants
|
20 participants
|
16 participants
|
13 participants
|
0 participants
|
|
Stinging/Burning at Visit 5 During PDT#2
Grade 3 - Severe
|
2 participants
|
5 participants
|
8 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 minutes post PDT #2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=31 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=37 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=31 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=41 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 5 Post PDT#2
Grade 0 - None
|
7 participants
|
2 participants
|
2 participants
|
10 participants
|
35 participants
|
|
Stinging/Burning at Visit 5 Post PDT#2
Grade 1 - MInimal
|
26 participants
|
18 participants
|
14 participants
|
22 participants
|
9 participants
|
|
Stinging/Burning at Visit 5 Post PDT#2
Grade 2 - Moderate
|
8 participants
|
15 participants
|
11 participants
|
9 participants
|
0 participants
|
|
Stinging/Burning at Visit 5 Post PDT#2
Grade 3 - Severe
|
0 participants
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 6
Grade 0 - None
|
47 participants
|
48 participants
|
44 participants
|
44 participants
|
43 participants
|
|
Stinging/Burning at Visit 6
Grade 1 - MInimal
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Stinging/Burning at Visit 6
Grade 2 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 6
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Outcome measures
| Measure |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Stinging/Burning at Visit 7
Grade 2 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Stinging/Burning at Visit 7
Grade 0 - None
|
47 participants
|
48 participants
|
44 participants
|
45 participants
|
46 participants
|
|
Stinging/Burning at Visit 7
Grade 1 - MInimal
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Stinging/Burning at Visit 7
Grade 3 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineSCALING 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Baseline
Grade 1 - Minimal
|
16 participants
|
19 participants
|
17 participants
|
15 participants
|
21 participants
|
|
Scaling and Dryness at Baseline
Grade 2 - Mild
|
6 participants
|
5 participants
|
4 participants
|
2 participants
|
6 participants
|
|
Scaling and Dryness at Baseline
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Baseline
Grade 0 - None
|
25 participants
|
24 participants
|
26 participants
|
29 participants
|
16 participants
|
|
Scaling and Dryness at Baseline
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 24-48 hours after PDT #1SCALING 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 2
Grade 1 - Minimal
|
13 participants
|
16 participants
|
15 participants
|
23 participants
|
22 participants
|
|
Scaling and Dryness at Visit 2
Grade 2 - Mild
|
10 participants
|
8 participants
|
4 participants
|
6 participants
|
6 participants
|
|
Scaling and Dryness at Visit 2
Grade 4 - Severe
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 2
Grade 0 - None
|
19 participants
|
20 participants
|
22 participants
|
17 participants
|
18 participants
|
|
Scaling and Dryness at Visit 2
Grade 3 - Moderate
|
5 participants
|
4 participants
|
5 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 2SCALING 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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 3
Grade 0 - None
|
22 participants
|
21 participants
|
20 participants
|
27 participants
|
19 participants
|
|
Scaling and Dryness at Visit 3
Grade 1 - Minimal
|
17 participants
|
15 participants
|
16 participants
|
16 participants
|
20 participants
|
|
Scaling and Dryness at Visit 3
Grade 2 - Mild
|
7 participants
|
8 participants
|
8 participants
|
3 participants
|
6 participants
|
|
Scaling and Dryness at Visit 3
Grade 3 - Moderate
|
1 participants
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 3
Grade 4 - Severe
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 4
Grade 1 - Minimal
|
19 participants
|
18 participants
|
17 participants
|
14 participants
|
22 participants
|
|
Scaling and Dryness at Visit 4
Grade 3 - Moderate
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Scaling and Dryness at Visit 4
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 4
Grade 0 - None
|
24 participants
|
24 participants
|
27 participants
|
28 participants
|
18 participants
|
|
Scaling and Dryness at Visit 4
Grade 2 - Mild
|
3 participants
|
6 participants
|
1 participants
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 5
Grade 0 - None
|
23 participants
|
30 participants
|
31 participants
|
31 participants
|
17 participants
|
|
Scaling and Dryness at Visit 5
Grade 1 - Minimal
|
21 participants
|
16 participants
|
11 participants
|
13 participants
|
18 participants
|
|
Scaling and Dryness at Visit 5
Grade 2 - Mild
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
9 participants
|
|
Scaling and Dryness at Visit 5
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 5
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 6
Grade 1 - Minimal
|
13 participants
|
12 participants
|
13 participants
|
11 participants
|
17 participants
|
|
Scaling and Dryness at Visit 6
Grade 2 - Mild
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
4 participants
|
|
Scaling and Dryness at Visit 6
Grade 3 - Moderate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 6
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 6
Grade 0 - None
|
32 participants
|
34 participants
|
30 participants
|
33 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Scaling and Dryness at Visit 7
Grade 0 - None
|
31 participants
|
26 participants
|
32 participants
|
37 participants
|
28 participants
|
|
Scaling and Dryness at Visit 7
Grade 2 - Mild
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
5 participants
|
|
Scaling and Dryness at Visit 7
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Scaling and Dryness at Visit 7
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Scaling and Dryness at Visit 7
Grade 1 - Minimal
|
13 participants
|
22 participants
|
11 participants
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: BaselineOOZING/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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Baseline
Grade 0 - None
|
45 participants
|
47 participants
|
46 participants
|
43 participants
|
44 participants
|
|
Oozing/Vesiculation/Crusting at Baseline
Grade 1 - Minimal
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting at Baseline
Grade 2 - Mild
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting at Baseline
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24-48 hours after PDT #1OOZING/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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 2
Grade 0 - None
|
43 participants
|
39 participants
|
34 participants
|
34 participants
|
43 participants
|
|
Oozing/Vesiculation/Crusting at Visit 2
Grade 1 - Minimal
|
2 participants
|
4 participants
|
5 participants
|
9 participants
|
2 participants
|
|
Oozing/Vesiculation/Crusting at Visit 2
Grade 2 - Mild
|
2 participants
|
4 participants
|
4 participants
|
2 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting at Visit 2
Grade 3 - Moderate
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 2
Grade 4 - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 2Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=47 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 3
Grade 2 - Mild
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 3
Grade 0 - None
|
45 participants
|
42 participants
|
45 participants
|
45 participants
|
45 participants
|
|
Oozing/Vesiculation/Crusting at Visit 3
Grade 1 - Minimal
|
1 participants
|
5 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 3
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=46 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=45 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 4
Grade 0 - None
|
46 participants
|
45 participants
|
46 participants
|
46 participants
|
45 participants
|
|
Oozing/Vesiculation/Crusting at Visit 4
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 4
Grade 1 - Minimal
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 4
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=45 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 5
Grade 0 - None
|
47 participants
|
47 participants
|
45 participants
|
44 participants
|
42 participants
|
|
Oozing/Vesiculation/Crusting at Visit 5
Grade 1 - Minimal
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting at Visit 5
Grade 2 - Mild
|
0 participants
|
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
|
1 participants
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=44 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 6
Grade 0 - None
|
46 participants
|
48 participants
|
44 participants
|
46 participants
|
44 participants
|
|
Oozing/Vesiculation/Crusting at Visit 6
Grade 1 - Minimal
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 6
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 6
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.
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 |
Broad Area ALA 1-hour + BLUE Light Treatment
n=47 Participants
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 2-hour + BLUE Light Treatment
n=48 Participants
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Broad Area ALA 3-hour + BLUE Light Treatment
n=44 Participants
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Spot ALA 2-hour + BLUE Light Treatment
n=46 Participants
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
|
Vehicle + BLUE Light Treatment
n=46 Participants
VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group.
|
|---|---|---|---|---|---|
|
Oozing/Vesiculation/Crusting at Visit 7
Grade 2 - Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 7
Grade 0 - None
|
47 participants
|
48 participants
|
44 participants
|
45 participants
|
46 participants
|
|
Oozing/Vesiculation/Crusting at Visit 7
Grade 1 - Minimal
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting at Visit 7
Grade 3 - Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Broad Area ALA 1-hour
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Broad Area ALA 2-hour
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Broad Area ALA 3-hour
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Spot ALA 2-hour
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Vehicle PDT
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Broad Area ALA 1-hour
n=48 participants at risk
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
|
Broad Area ALA 2-hour
n=48 participants at risk
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
|
Broad Area ALA 3-hour
n=47 participants at risk
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
|
Spot ALA 2-hour
n=46 participants at risk
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
|
Vehicle PDT
n=46 participants at risk
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Kidney stone
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Nervous system disorders
transient ischemic attack
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Infections and infestations
community-acquired pneumonia
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Vascular disorders
deep vein thrombosis
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary emboli
|
2.1%
1/48 • Number of events 2
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Infections and infestations
upper respiratory infection
|
2.1%
1/48 • Number of events 1
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
leukemia
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
0.00%
0/46
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
0.00%
0/47
|
0.00%
0/46
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/48
|
0.00%
0/48
|
2.1%
1/47 • Number of events 1
|
0.00%
0/46
|
0.00%
0/46
|
|
Gastrointestinal disorders
gastrointestinal bleed
|
0.00%
0/48
|
0.00%
0/48
|
2.1%
1/47 • Number of events 1
|
0.00%
0/46
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
renal cell carcinoma
|
0.00%
0/48
|
0.00%
0/48
|
2.1%
1/47 • Number of events 1
|
0.00%
0/46
|
0.00%
0/46
|
|
Nervous system disorders
stroke
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/47
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/47
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
small bowel obstruction
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Cardiac disorders
exacerbation of atrial fibrillation
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Surgical and medical procedures
splenectomy
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/47
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
Other adverse events
| Measure |
Broad Area ALA 1-hour
n=48 participants at risk
Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
|
Broad Area ALA 2-hour
n=48 participants at risk
Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
|
Broad Area ALA 3-hour
n=47 participants at risk
broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
|
Spot ALA 2-hour
n=46 participants at risk
Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
|
Vehicle PDT
n=46 participants at risk
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma of skin
|
0.00%
0/48
|
2.1%
1/48 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
8.7%
4/46 • Number of events 5
|
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