Acne Vulgaris
Conditions
Brief summary
Bioequivalence with Clinical Endpoints.
Detailed description
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Interventions
DRUGAdapalene/BP gel, 0.3%/2.5%
Gel
DRUGEPIDUO® FORTE
Gel
DRUGPlacebo
Gel
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory lesion counts | Week 12 | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts |
| Change in non-inflammatory lesion counts | Week 12 | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response of success | Week 12 | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment |
Outcome results
None listed