Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications
|Acne Vulgaris||Drug: clindamycin and benzoyl peroxide Drug: Dapsone gel||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Clindamycin and Benzoyl Peroxide to Dapsone Gel Topical Acne Medications|
- Skin Erythema (Redness) [ Time Frame: 2 Weeks ]
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.
Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
- Skin Dryness [ Time Frame: Baseline, Day 1through Day 14 ]
The amount of dryness on the left and right cheek of each panelist.
The scale used to evaluate skin dryness is:
Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring
Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
- Transepidermal Water Loss (TEWL) [ Time Frame: 2 Weeks ]To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.
- Sebum Measurements [ Time Frame: 2 weeks ]To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.
- Skin Hydration [ Time Frame: 2 weeks ]Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.
|Study Start Date:||July 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: Clindamycin/BPO gel
Once-daily applications of clindamycin/BPO gel to the randomized side of the face either left or right.
Drug: clindamycin and benzoyl peroxide
Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide
Other Name: Duac® gel
Active Comparator: Dapsone gel
Twice-daily applications of dapsone gel to one side of the face.
Drug: Dapsone gel
Twice-daily applications of dapsone gel
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.
The eligible subjects who qualify will be entered into a 2-week treatment phase. The first of application of the study medication will be supervised at the site, Monday through Friday of each week. Any additional applications should be applied by the subjects at home each evening and the times of application recorded on a diary card. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.
A blinded expert grader will rate comparative product tolerance during the study before study product is applied.
Instrumentation measurements of TEWL will be utilized to evaluate product mildness.
Duplicate sebum samples will be taken from the left and right forehead areas and assessed.
Subject will complete questionnaires and all adverse events will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964366
|United States, Pennsylvania|
|Broomall, Pennsylvania, United States, 19008|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|