To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

Overview

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Full Title of Study: “A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% 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: Single (Investigator)
  • Study Primary Completion Date: January 26, 2018

Detailed Description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Interventions

  • Drug: Tretinoin cream 0.1%
    • Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
  • Drug: RETIN-A® Cream
    • RETIN-A® (Tretinoin) Cream (Valeant)
  • Drug: Vehicle of the test product
    • Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Arms, Groups and Cohorts

  • Experimental: Tretinoin cream 0.1%
    • Once daily at home, to apply the entire affected areas of the face.
  • Active Comparator: RETIN-A® Cream
    • Once daily at home, to apply the entire affected areas of the face.
  • Placebo Comparator: Vehicle of the test product
    • Once daily at home, to apply the entire affected areas of the face.

Clinical Trial Outcome Measures

Primary Measures

  • Demonstration of Bioequivalence
    • Time Frame: 12 weeks
    • Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. – Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA). – Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 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: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zaidoon A Al-Zubaidy, Study Director, Catawba Research

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