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A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT04724473
Collaborator
(none)
1,030
Enrollment
1
Location
3
Arms
11.4
Actual Duration (Months)
90.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tretinoin Cream 0.025%
 Early Phase 1

Detailed Description

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Study Design

Study Type:
Interventional
Actual Enrollment :
1030 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris
Actual Study Start Date :
Dec 10, 2019
Actual Primary Completion Date :
Nov 21, 2020
Actual Study Completion Date :
Nov 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tretinoin Cream 0.025%

The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Drug: Tretinoin Cream 0.025%
The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other Names:
  • Tretinoin

    		•
    Active Comparator: RETIN-A® (Tretinoin) Cream 0.025%

    The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

    Drug: Tretinoin Cream 0.025%
    The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
    Other Names:
  • Tretinoin

    		•
    Placebo Comparator: Placebo Control

    The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

    Drug: Tretinoin Cream 0.025%
    The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
    Other Names:
  • Tretinoin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Demonstration of Bioequivalence [Baseline to Week 12]

      To evaluate the percentage change in the inflammatory and non-inflammatory lesion counts

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years 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 12 to 17 years of age, inclusive, must have provided IRB approved written assent

    • 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 tretinoin, retinoids, or any of the study medication ingredients.

    • Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catawba Research, LLC Charlotte North Carolina United States 28217

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Director: Zaidoon A. Al-Zubaidy, Catawba Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT04724473
    Other Study ID Numbers:
    • TRTC-1912
    First Posted:
    Jan 26, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Tretinoin

    Study Results

    No Results Posted as of Apr 1, 2021