Trial Outcomes & Findings for Photodynamic Therapy for Papulopustular Rosacea (NCT NCT02075671)
NCT ID: NCT02075671
Last Updated: 2022-12-29
Results Overview
The Investigator's global assessment (IGA) of rosacea is a subjective 7-point, static scoring system. Scores range from 0 to 6: 0 (clear), 1 (minimal), 2 (mild), 3 (mild to moderate), 4 (moderate), 5 (moderate to severe), 6 (severe).
COMPLETED
PHASE4
30 participants
17 weeks
2022-12-29
Participant Flow
Participant milestones
| Measure |
Levulan and Blu-U Light
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy for Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
Levulan and Blu-U Light
n=10 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=10 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
I
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
II
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
III
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
V
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 17 weeksPopulation: Group A = Levulan and Blu-U Light; Group B = Vehicle and Blu-U Light; Group C = Vehicle Only. Of the 30 randomized patients, 24 (80%) completed the entire study. 8 (80%) patients completed from Group A, 10 (100%) from Group B, and 6 (60%) from Group C.
The Investigator's global assessment (IGA) of rosacea is a subjective 7-point, static scoring system. Scores range from 0 to 6: 0 (clear), 1 (minimal), 2 (mild), 3 (mild to moderate), 4 (moderate), 5 (moderate to severe), 6 (severe).
Outcome measures
| Measure |
Levulan and Blu-U Light
n=8 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=6 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)
|
2.8 score on a scale
Standard Deviation 0.5
|
1.5 score on a scale
Standard Deviation 1.6
|
1.5 score on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 17 weeksPopulation: Group A = Levulan and Blu-U Light; Group B = Vehicle and Blu-U Light; Group C = Vehicle Only. Of the 30 randomized patients, 24 (80%) completed the entire study. 8 (80%) patients completed from Group A, 10 (100%) from Group B, and 6 (60%) from Group C.
The Inflammatory Lesion Investigator's Global Assessment (ILIGA) is a subjective 5-point measure of the overall disease severity. Scores range from 0 to 4: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe).
Outcome measures
| Measure |
Levulan and Blu-U Light
n=8 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=6 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)
|
1.3 score on a scale
Standard Deviation 0.9
|
0.8 score on a scale
Standard Deviation 1.2
|
1.0 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Group A = Levulan and Blu-U Light; Group B = Vehicle and Blu-U Light; Group C = Vehicle Only. Of the 30 randomized patients, 24 (80%) completed the entire study. 8 (80%) patients completed from Group A, 10 (100%) from Group B, and 6 (60%) from Group C.
The Clinical Erythema Assessment (CEA) scale is an assessment of erythema. It has a score range from 0 to 4: 0 (none), 1 (mild), 2 (moderate), 3 (significant), 4 (severe). The total score is based on the evaluation of all areas of the face (forehead, chin, right cheek, left cheek, and nose). Each of these areas were scored from 0-4, giving a maximum total score of 20.
Outcome measures
| Measure |
Levulan and Blu-U Light
n=8 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=6 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale
|
6.0 score on a scale
Standard Deviation 2.1
|
4.5 score on a scale
Standard Deviation 3.6
|
1.2 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Group A = Levulan and Blu-U Light; Group B = Vehicle and Blu-U Light; Group C = Vehicle Only. Of the 30 randomized patients, 24 (80%) completed the entire study. 8 (80%) patients completed from Group A, 10 (100%) from Group B, and 6 (60%) from Group C.
The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator.
Outcome measures
| Measure |
Levulan and Blu-U Light
n=8 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=6 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)
|
10.8 Inflammatory Lesion Count
Standard Deviation 2.9
|
3.4 Inflammatory Lesion Count
Standard Deviation 7.0
|
6.2 Inflammatory Lesion Count
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 17 weeksPopulation: Group A = Levulan and Blu-U Light; Group B = Vehicle and Blu-U Light; Group C = Vehicle Only. 8 (80%) patients completed from Group A, 10 (100%) from Group B, and 6 (60%) from Group C. One participant in Group B did not complete the POA scale at the last follow-up visit; therefore only 9 participants are included in the analysis for Group B.
For the Patient Overall Assessments (POA) scale, patients assessed the overall improvement of their rosacea using a 4-point scale, where 1 = excellent improvement, 2 = good/moderate improvement, 3 = no change, 4 = worsening.
Outcome measures
| Measure |
Levulan and Blu-U Light
n=8 Participants
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=9 Participants
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=6 Participants
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale
|
0.9 score on a scale
Standard Deviation 1.0
|
0.6 score on a scale
Standard Deviation 0.9
|
0.3 score on a scale
Standard Deviation 0.8
|
Adverse Events
Levulan and Blu-U Light
Vehicle and Blu-U Light
Vehicle Only
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levulan and Blu-U Light
n=10 participants at risk
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Aminolevulinic acid topical solution 20%: Intervention used in the experimental arm only
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle and Blu-U Light
n=10 participants at risk
Entire face treated with vehicle substance only and Blu-U light
Blu-U Light Therapy: Intervention used in experimental and sham arms
|
Vehicle Only
n=10 participants at risk
Entire face treated with vehicle substance only
Placebo vehicle only: Intervention only includes the placebo vehicle solution
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
1/10 • Number of events 1 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
10.0%
1/10 • Number of events 1 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
|
Skin and subcutaneous tissue disorders
Post-Treatment Erythema
|
10.0%
1/10 • Number of events 1 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
0.00%
0/10 • Adverse events were assessed for each patient from the baseline visit to up to 2 months following the final treatment, which averages from 17 to 19 weeks per patient.
|
Additional Information
Dermatology Research Fellow
The George Washington University, Medical Faculty Associates
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place