Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris

Phase 1CompletedNCT02709902

Sun Pharmaceutical Industries, Inc.460 enrolled

Overview

Bioequivalence with Clinical Endpoints.

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

460

Conditions

Acne Vulgaris

Interventions

Adapalene/BP gel, 0.3%/2.5%DRUG

Gel

EPIDUO® FORTEDRUG

Gel

PlaceboDRUG

Gel

Eligibility

Sex: ALLMin age: 12 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in inflammatory lesion counts

Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts

Time frame: Week 12

Change in non-inflammatory lesion counts

Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Time frame: Week 12

Secondary Outcomes

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

Time frame: Week 12

Data from ClinicalTrials.gov

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