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

Overview

Bioequivalence with Clinical Endpoints.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2016

Detailed Description

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

Interventions

  • Drug: Adapalene/BP gel, 0.3%/2.5%
    • Gel
  • Drug: EPIDUO® FORTE
    • Gel
  • Drug: Placebo
    • Gel

Arms, Groups and Cohorts

  • Experimental: Adapalene/BP gel, 0.3%/2.5%
    • Topical, once daily, for 84 days.
  • Active Comparator: EPIDUO® FORTE
    • Topical, once daily, for 84 days.
  • Placebo Comparator: Placebo
    • Topical, once daily, for 84 days.

Clinical Trial Outcome Measures

Primary Measures

  • Change in inflammatory lesion counts
    • Time Frame: Week 12
    • Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
  • Change in non-inflammatory lesion counts
    • Time Frame: Week 12
    • Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

Secondary Measures

  • Clinical response of success
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catawba Research, Study Chair, http://catawbaresearch.com/contact/

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