Acne Vulgaris Clinical Trial
Official title:
A Multi-center, Double-blind, Randomized, Placebo, Controlled, Parallel-group Study, Comparing Adapalene/BP Gel, 0.3%/2.5% to EPIDUO® FORTE GEL and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Verified date | May 2017 |
Source | Taro Pharmaceuticals USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bioequivalence with Clinical Endpoints.
Status | Completed |
Enrollment | 460 |
Est. completion date | March 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Taro Pharmaceuticals USA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 | |
Primary | Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 | |
Secondary | Clinical response of success | 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 | Week 12 |
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