Trial Outcomes & Findings for Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities (NCT NCT02137785)
NCT ID: NCT02137785
Last Updated: 2015-09-16
Results Overview
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
COMPLETED
PHASE3
269 participants
Week 12
2015-09-16
Participant Flow
Participant milestones
| Measure |
ALA-PDT
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
134
|
|
Overall Study
COMPLETED
|
132
|
130
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
ALA-PDT
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
subject moved out of state
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
Baseline characteristics by cohort
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Skin Type
Type I
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Skin Type
Type II
|
67 participants
n=5 Participants
|
73 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Skin Type
Type III
|
37 participants
n=5 Participants
|
32 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Skin Type
Type IV
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Skin Type
Type V
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Skin Type
Type VI
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Total Number AK Lesions (Grade 1/2)
|
8.5 lesions per subject
STANDARD_DEVIATION 3.6 • n=5 Participants
|
8.6 lesions per subject
STANDARD_DEVIATION 3.4 • n=7 Participants
|
8.5 lesions per subject
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Age, Continuous
|
67.6 years
n=5 Participants
|
67.6 years
n=7 Participants
|
67.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Complete Clearance Rate
|
42 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT using observed data only
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
AK Clearance Rate
|
69.1 percentage of baseline lesions cleared
Standard Deviation 37.4
|
29.9 percentage of baseline lesions cleared
Standard Deviation 51.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT using observed data only
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Outcome measures
| Measure |
ALA-PDT
n=133 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
AK Clearance Rate
|
53.4 percentage of baseline lesions cleared
Standard Deviation 45.0
|
26.3 percentage of baseline lesions cleared
Standard Deviation 44.3
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Complete Clearance Rate
|
35 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Outcome measures
| Measure |
ALA-PDT
n=134 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=131 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Subject Satisfaction Score
Very Satisfied
|
71 participants
|
29 participants
|
|
Subject Satisfaction Score
Moderately Satisfied
|
47 participants
|
26 participants
|
|
Subject Satisfaction Score
Slightly Satisfied
|
12 participants
|
28 participants
|
|
Subject Satisfaction Score
Not Satisfied
|
4 participants
|
48 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 0 (none)
|
46 participants
|
53 participants
|
|
Hyperpigmentation
Grade 1 (light)
|
51 participants
|
34 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
27 participants
|
35 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
10 participants
|
10 participants
|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 0 (none)
|
46 participants
|
58 participants
|
|
Hyperpigmentation
Grade 1 (light)
|
49 participants
|
34 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
28 participants
|
30 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
11 participants
|
10 participants
|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 0 (none)
|
45 participants
|
58 participants
|
|
Hyperpigmentation
Grade 1 (light)
|
46 participants
|
35 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
33 participants
|
30 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
10 participants
|
9 participants
|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 1 (light)
|
44 participants
|
37 participants
|
|
Hyperpigmentation
Grade 0 (none)
|
51 participants
|
56 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
30 participants
|
28 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
9 participants
|
9 participants
|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
|
Hyperpigmentation
Grade 0 (none)
|
51 participants
|
53 participants
|
|
Hyperpigmentation
Grade 1 (light)
|
44 participants
|
37 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
27 participants
|
27 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
9 participants
|
10 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hyperpigmentation
Grade 1 (light)
|
42 participants
|
43 participants
|
|
Hyperpigmentation
Grade 2 (moderate - small)
|
29 participants
|
26 participants
|
|
Hyperpigmentation
Grade 0 (none)
|
52 participants
|
49 participants
|
|
Hyperpigmentation
Grade 3 (moderate - moderate)
|
8 participants
|
10 participants
|
|
Hyperpigmentation
Grade 4 (marked)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
75 participants
|
64 participants
|
|
Hypopigmentation
Grade 1 (light)
|
40 participants
|
47 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
16 participants
|
17 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
4 participants
|
4 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
76 participants
|
68 participants
|
|
Hypopigmentation
Grade 1 (light)
|
42 participants
|
46 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
12 participants
|
14 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
5 participants
|
4 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
74 participants
|
67 participants
|
|
Hypopigmentation
Grade 1 (light)
|
44 participants
|
47 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
13 participants
|
14 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
4 participants
|
4 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
76 participants
|
65 participants
|
|
Hypopigmentation
Grade 1 (light)
|
42 participants
|
47 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
13 participants
|
14 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
4 participants
|
4 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
75 participants
|
63 participants
|
|
Hypopigmentation
Grade 1 (light)
|
39 participants
|
45 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
15 participants
|
15 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
3 participants
|
4 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Hypopigmentation
Grade 0 (none)
|
73 participants
|
66 participants
|
|
Hypopigmentation
Grade 1 (light)
|
40 participants
|
45 participants
|
|
Hypopigmentation
Grade 2 (moderate - small)
|
16 participants
|
14 participants
|
|
Hypopigmentation
Grade 3 (moderate - moderate)
|
3 participants
|
3 participants
|
|
Hypopigmentation
Grade 4 (marked)
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
73 participants
|
73 participants
|
|
Erythema
Grade 2 (mild)
|
21 participants
|
19 participants
|
|
Erythema
Grade 4 (severe)
|
0 participants
|
0 participants
|
|
Erythema
Grade 1 (minimal)
|
38 participants
|
39 participants
|
|
Erythema
Grade 3 (moderate)
|
3 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minutes after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
12 participants
|
57 participants
|
|
Erythema
Grade 1 (light)
|
26 participants
|
41 participants
|
|
Erythema
Grade 2 (mild)
|
43 participants
|
27 participants
|
|
Erythema
Grade 3 (moderate)
|
52 participants
|
9 participants
|
|
Erythema
Grade 4 (severe)
|
2 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
2 participants
|
64 participants
|
|
Erythema
Grade 1 (minimal)
|
16 participants
|
43 participants
|
|
Erythema
Grade 2 (mild)
|
48 participants
|
23 participants
|
|
Erythema
Grade 3 (moderate)
|
66 participants
|
4 participants
|
|
Erythema
Grade 4 (severe)
|
3 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
28 participants
|
61 participants
|
|
Erythema
Grade 1 (minimal)
|
46 participants
|
58 participants
|
|
Erythema
Grade 2 (mild)
|
51 participants
|
14 participants
|
|
Erythema
Grade 3 (moderate)
|
10 participants
|
1 participants
|
|
Erythema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
54 participants
|
72 participants
|
|
Erythema
Grade 1 (minimal)
|
54 participants
|
49 participants
|
|
Erythema
Grade 2 (mild)
|
24 participants
|
11 participants
|
|
Erythema
Grade 3 (moderate)
|
3 participants
|
0 participants
|
|
Erythema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
79 participants
|
81 participants
|
|
Erythema
Grade 1 (minimal)
|
30 participants
|
39 participants
|
|
Erythema
Grade 2 (mild)
|
18 participants
|
7 participants
|
|
Erythema
Grade 3 (moderate)
|
5 participants
|
2 participants
|
|
Erythema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Erythema
Grade 0 (none)
|
80 participants
|
85 participants
|
|
Erythema
Grade 1 (minimal)
|
34 participants
|
36 participants
|
|
Erythema
Grade 2 (mild)
|
15 participants
|
8 participants
|
|
Erythema
Grade 3 (moderate)
|
3 participants
|
1 participants
|
|
Erythema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
133 participants
|
134 participants
|
|
Edema
Grade 1 (minimal)
|
2 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
0 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minutes after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
92 participants
|
127 participants
|
|
Edema
Grade 1 (minimal)
|
30 participants
|
7 participants
|
|
Edema
Grade 2 (mild)
|
10 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
3 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
89 participants
|
133 participants
|
|
Edema
Grade 1 (minimal)
|
27 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
18 participants
|
1 participants
|
|
Edema
Grade 3 (moderate)
|
1 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
131 participants
|
134 participants
|
|
Edema
Grade 1 (minimal)
|
4 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
0 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
134 participants
|
132 participants
|
|
Edema
Grade 1 (minimal)
|
1 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
0 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
131 participants
|
128 participants
|
|
Edema
Grade 1 (minimal)
|
0 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
1 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
0 participants
|
1 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Edema
Grade 0 (none)
|
132 participants
|
130 participants
|
|
Edema
Grade 1 (minimal)
|
0 participants
|
0 participants
|
|
Edema
Grade 2 (mild)
|
0 participants
|
0 participants
|
|
Edema
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Edema
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
134 participants
|
133 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
1 participants
|
0 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
0 participants
|
1 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
10 participants
|
111 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
39 participants
|
23 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
74 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
12 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minutes after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
30 participants
|
130 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
70 participants
|
4 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
35 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 Hours after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
107 participants
|
132 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
23 participants
|
2 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
5 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
131 ITT
|
134 ITT
|
|
Stinging/Burning
Grade 1 (mild)
|
3 ITT
|
0 ITT
|
|
Stinging/Burning
Grade 2 (moderate)
|
0 ITT
|
0 ITT
|
|
Stinging/Burning
Grade 3 (severe)
|
1 ITT
|
0 ITT
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
132 participants
|
132 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
2 participants
|
0 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
1 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
130 participants
|
129 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
2 participants
|
0 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
0 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Stinging/Burning
Grade 0 (none)
|
130 participants
|
130 participants
|
|
Stinging/Burning
Grade 1 (mild)
|
1 participants
|
0 participants
|
|
Stinging/Burning
Grade 2 (moderate)
|
1 participants
|
0 participants
|
|
Stinging/Burning
Grade 3 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
83 participants
|
78 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
35 participants
|
41 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
10 participants
|
11 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
7 participants
|
4 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
84 participants
|
79 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
30 participants
|
40 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
17 participants
|
10 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
4 participants
|
5 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
33 participants
|
81 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
47 participants
|
38 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
29 participants
|
11 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
26 participants
|
4 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
73 participants
|
83 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
44 participants
|
38 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
15 participants
|
11 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
3 participants
|
0 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
83 participants
|
86 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
35 participants
|
35 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
11 participants
|
5 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
3 participants
|
3 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Scaling & Dryness
Grade 0 (none)
|
85 participants
|
86 participants
|
|
Scaling & Dryness
Grade 1 (minimal)
|
33 participants
|
32 participants
|
|
Scaling & Dryness
Grade 2 (mild)
|
9 participants
|
10 participants
|
|
Scaling & Dryness
Grade 3 (moderate)
|
5 participants
|
2 participants
|
|
Scaling & Dryness
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
128 participants
|
129 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
7 participants
|
4 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
0 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-48 hours after PDT #1Population: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
116 participants
|
127 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
12 participants
|
3 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
5 participants
|
3 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
2 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 Weeks after PDT #1Population: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
92 participants
|
129 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
23 participants
|
4 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
16 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
4 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 Weeks after PDT #1Population: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=135 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=132 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
121 participants
|
129 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
12 participants
|
2 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
2 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 Weeks after PDT #1Population: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=129 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
125 participants
|
124 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
5 participants
|
3 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
2 participants
|
2 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
0 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks after PDT #1Population: ITT
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Outcome measures
| Measure |
ALA-PDT
n=132 Participants
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=130 Participants
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Oozing/Vesiculation/Crusting
Grade 0 (none)
|
123 participants
|
125 participants
|
|
Oozing/Vesiculation/Crusting
Grade 1 (minimal)
|
5 participants
|
4 participants
|
|
Oozing/Vesiculation/Crusting
Grade 2 (mild)
|
3 participants
|
0 participants
|
|
Oozing/Vesiculation/Crusting
Grade 3 (moderate)
|
1 participants
|
1 participants
|
|
Oozing/Vesiculation/Crusting
Grade 4 (severe)
|
0 participants
|
0 participants
|
Adverse Events
ALA-PDT
Vehicle
Serious adverse events
| Measure |
ALA-PDT
n=135 participants at risk
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 participants at risk
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Cardiac disorders
Angina Unstable
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/135 • 3 months
|
0.75%
1/134 • Number of events 1 • 3 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Cardiac disorders
Chest Pressure
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/135 • 3 months
|
0.75%
1/134 • Number of events 1 • 3 months
|
|
Infections and infestations
Appendicitis
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Nervous system disorders
Dizziness
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Nervous system disorders
Syncope
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/135 • Number of events 4 • 3 months
|
0.00%
0/134 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.74%
1/135 • Number of events 1 • 3 months
|
0.00%
0/134 • 3 months
|
Other adverse events
| Measure |
ALA-PDT
n=135 participants at risk
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
Vehicle
n=134 participants at risk
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.5%
2/135 • 3 months
|
3.0%
4/134 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
3.0%
4/135 • 3 months
|
1.5%
2/134 • 3 months
|
Additional Information
Anna Houlihan
DUSA Pharmaceuticals Inc., a Sun Pharma Co.
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 30-75 days before submission so that sponsor can review the publication for confidential information.
- Publication restrictions are in place
Restriction type: OTHER