Acne Vulgaris
Conditions
Brief summary
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
Interventions
DRUGAdapalene BPO
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/
Exclusion criteria
. Main inclusion criteria: 1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, 2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, 3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose. Main
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit | — |
| Global severity assessment at each post Baseline visit | — |
Countries
United States
Outcome results
None listed