Trial Outcomes & Findings for Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2) (NCT NCT02628236)
NCT ID: NCT02628236
Last Updated: 2017-09-18
Results Overview
Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
COMPLETED
PHASE2
14 participants
2 days
2017-09-18
Participant Flow
Participant milestones
| Measure |
ALA-PDT
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
Baseline characteristics by cohort
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 daysMaximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
|
39.05 ng/mL
Geometric Coefficient of Variation 319.7
|
PRIMARY outcome
Timeframe: 2 daysTime of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Time at Which Cmax is Attained (Tmax) for ALA
|
2 hours
Interval 0.25 to 36.0
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-doseAUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
AUCt
|
182.1 ng*hr/mL
Geometric Coefficient of Variation 111.6
|
PRIMARY outcome
Timeframe: 2 daysPopulation: T1/2,z could not be determined in 11 subjects
The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.
Outcome measures
| Measure |
ALA-PDT
n=3 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
The Terminal Exponential Half-life (T1/2,z) for ALA
|
5.386 hours
Geometric Coefficient of Variation 253.7
|
PRIMARY outcome
Timeframe: 2 daysPopulation: For 50% of the subjects, more than 50% of the PpIX plasma concentrations following topical application of ALA HCI were less than the predose plasma concentration. Therefore, negative values were set to 0 to evaluate median baseline corrected plasma concentration.
Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX
|
0.735 ng/mL
Interval 0.0 to 2.3
|
PRIMARY outcome
Timeframe: 2 daysPopulation: One subject had tmax that could not be determined.
Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.
Outcome measures
| Measure |
ALA-PDT
n=13 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Time at Which Cmax is Attained (Tmax) for PpIX
|
12 hours
Interval 0.25 to 48.0
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-doseThe area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
AUCBL for PpIX
|
77.34 ng*hr/mL
Geometric Coefficient of Variation 98.04
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-doseThe area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
AUCt for PpIX
|
77.00 ng*hr/mL
Geometric Coefficient of Variation 59.16
|
PRIMARY outcome
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-doseThe ratio of AUCt to AUCBL for PpIX
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
AUCt/AUCBL for PpIX
|
0.9956 ratio
Interval 0.831 to 1.19
|
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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hyperpigmentation
Grade 0
|
6 Participants
|
|
Hyperpigmentation
Grade 1
|
7 Participants
|
|
Hyperpigmentation
Grade 2
|
1 Participants
|
|
Hyperpigmentation
Grade 3
|
0 Participants
|
|
Hyperpigmentation
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTHYPERPIGMENTATION 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hyperpigmentation
Grade 0
|
7 Participants
|
|
Hyperpigmentation
Grade 1
|
6 Participants
|
|
Hyperpigmentation
Grade 2
|
1 Participants
|
|
Hyperpigmentation
Grade 3
|
0 Participants
|
|
Hyperpigmentation
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4HYPERPIGMENTATION 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hyperpigmentation
Grade 0
|
7 Participants
|
|
Hyperpigmentation
Grade 1
|
6 Participants
|
|
Hyperpigmentation
Grade 2
|
1 Participants
|
|
Hyperpigmentation
Grade 3
|
0 Participants
|
|
Hyperpigmentation
Grade 4
|
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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hypopigmentation
Grade 0
|
8 Participants
|
|
Hypopigmentation
Grade 1
|
6 Participants
|
|
Hypopigmentation
Grade 2
|
0 Participants
|
|
Hypopigmentation
Grade 3
|
0 Participants
|
|
Hypopigmentation
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTHYPOPIGMENTATION 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hypopigmentation
Grade 0
|
8 Participants
|
|
Hypopigmentation
Grade 1
|
6 Participants
|
|
Hypopigmentation
Grade 2
|
0 Participants
|
|
Hypopigmentation
Grade 3
|
0 Participants
|
|
Hypopigmentation
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4HYPOPIGMENTATION 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Hypopigmentation
Grade 0
|
8 Participants
|
|
Hypopigmentation
Grade 1
|
6 Participants
|
|
Hypopigmentation
Grade 2
|
0 Participants
|
|
Hypopigmentation
Grade 3
|
0 Participants
|
|
Hypopigmentation
Grade 4
|
0 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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Erythema
Grade 0
|
11 Participants
|
|
Erythema
Grade 1
|
1 Participants
|
|
Erythema
Grade 2
|
2 Participants
|
|
Erythema
Grade 3
|
0 Participants
|
|
Erythema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 Minutes after PDTErythema 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Erythema
Grade 0
|
4 Participants
|
|
Erythema
Grade 1
|
2 Participants
|
|
Erythema
Grade 2
|
5 Participants
|
|
Erythema
Grade 3
|
3 Participants
|
|
Erythema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTErythema 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Erythema
Grade 0
|
0 Participants
|
|
Erythema
Grade 1
|
3 Participants
|
|
Erythema
Grade 2
|
4 Participants
|
|
Erythema
Grade 3
|
7 Participants
|
|
Erythema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4Erythema 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Erythema
Grade 0
|
7 Participants
|
|
Erythema
Grade 1
|
6 Participants
|
|
Erythema
Grade 2
|
1 Participants
|
|
Erythema
Grade 3
|
0 Participants
|
|
Erythema
Grade 4
|
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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Edema
Grade 0
|
14 Participants
|
|
Edema
Grade 1
|
0 Participants
|
|
Edema
Grade 2
|
0 Participants
|
|
Edema
Grade 3
|
0 Participants
|
|
Edema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 Minutes after PDTEDEMA 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Edema
Grade 0
|
8 Participants
|
|
Edema
Grade 1
|
5 Participants
|
|
Edema
Grade 2
|
1 Participants
|
|
Edema
Grade 3
|
0 Participants
|
|
Edema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTEDEMA 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Edema
Grade 0
|
8 Participants
|
|
Edema
Grade 1
|
3 Participants
|
|
Edema
Grade 2
|
3 Participants
|
|
Edema
Grade 3
|
0 Participants
|
|
Edema
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4EDEMA 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Edema
Grade 0
|
14 Participants
|
|
Edema
Grade 1
|
0 Participants
|
|
Edema
Grade 2
|
0 Participants
|
|
Edema
Grade 3
|
0 Participants
|
|
Edema
Grade 4
|
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
Outcome measures
| Measure |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Stinging/Burning
Grade 0
|
13 Participants
|
|
Stinging/Burning
Grade 1
|
1 Participants
|
|
Stinging/Burning
Grade 2
|
0 Participants
|
|
Stinging/Burning
Grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: IntraprocedureSTINGING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Stinging/Burning
Grade 0
|
0 Participants
|
|
Stinging/Burning
Grade 1
|
6 Participants
|
|
Stinging/Burning
Grade 2
|
8 Participants
|
|
Stinging/Burning
Grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 Minutes after photodynamic therapySTINGING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Stinging/Burning
Grade 0
|
6 Participants
|
|
Stinging/Burning
Grade 1
|
5 Participants
|
|
Stinging/Burning
Grade 2
|
3 Participants
|
|
Stinging/Burning
Grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTSTINGING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Stinging/Burning
g
|
10 Participants
|
|
Stinging/Burning
Grade 1
|
4 Participants
|
|
Stinging/Burning
Grade 2
|
0 Participants
|
|
Stinging/Burning
Grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4STINGING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Stinging/Burning
Grade 0
|
13 Participants
|
|
Stinging/Burning
Grade 1
|
1 Participants
|
|
Stinging/Burning
Grade 2
|
0 Participants
|
|
Stinging/Burning
Grade 3
|
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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Scaling and Dryness
Grade 0
|
12 Participants
|
|
Scaling and Dryness
Grade 1
|
2 Participants
|
|
Scaling and Dryness
Grade 2
|
0 Participants
|
|
Scaling and Dryness
Grade 3
|
0 Participants
|
|
Scaling and Dryness
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTSCALING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Scaling and Dryness at Visit 4
Grade 0
|
9 Participants
|
|
Scaling and Dryness at Visit 4
Grade 1
|
3 Participants
|
|
Scaling and Dryness at Visit 4
Grade 2
|
1 Participants
|
|
Scaling and Dryness at Visit 4
Grade 3
|
1 Participants
|
|
Scaling and Dryness at Visit 4
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4SCALING 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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Scaling and Dryness
Grade 0
|
9 Participants
|
|
Scaling and Dryness
Grade 1
|
5 Participants
|
|
Scaling and Dryness
Grade 2
|
0 Participants
|
|
Scaling and Dryness
Grade 3
|
0 Participants
|
|
Scaling and Dryness
Grade 4
|
0 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 |
ALA-PDT
n=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
OOZING/VESICULATION/CRUSTING
Grade 0
|
14 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 1
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 2
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 3
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after PDTOOZING/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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
OOZING/VESICULATION/CRUSTING
Grade 0
|
13 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 1
|
1 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 2
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 3
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4OOZING/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=14 Participants
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
OOZING/VESICULATION/CRUSTING
Grade 0
|
14 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 1
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 2
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 3
|
0 Participants
|
|
OOZING/VESICULATION/CRUSTING
Grade 4
|
0 Participants
|
Adverse Events
ALA-PDT
Serious adverse events
| Measure |
ALA-PDT
n=14 participants at risk
20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment
Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
|
|---|---|
|
Vascular disorders
deep vein thrombosis
|
7.1%
1/14 • 4 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Anna Houlihan
DUSA Pharmaceuticals Inc., a Sun Pharma Co.
Results disclosure agreements
- Principal investigator is a sponsor employee First publication of results will be made by the Sponsor. If publication is not submitted within 12 months after the date of study final report, the PI may publish the results from the site individually, subject to compliance with the other terms of the clinical trial agreement, including a requirement that the PI provide a draft of the publication for the sponsor's review 30 days before submission for publication so that sponsor can review the publication for confidential information
- Publication restrictions are in place
Restriction type: OTHER