Acne Vulgaris
Conditions
Brief summary
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Detailed description
Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Interventions
A thin film of investigation product will be applied to the affected areas of the face once daily
DRUGClindamycin Phosphate RLD
A thin film of investigation product will be applied to the affected areas of the face once daily
DRUGPlacebos
A thin film of investigation product will be applied to the affected areas of the face once daily
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. * Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. * Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation * Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstration of Bioequivalence | Week 12 | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts |
Countries
United States
Outcome results
None listed