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A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT04883736
Collaborator
(none)
973
Enrollment
1
Location
3
Arms
7.5
Actual Duration (Months)
129.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tretinoin Gel Microsphere, 0.1%
  • Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
  • Drug: Placebo Control
 Early Phase 1

Detailed Description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Study Design

Study Type:
Interventional
Actual Enrollment :
973 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 Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) to RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Actual Study Start Date :
Aug 31, 2020
Actual Primary Completion Date :
Apr 16, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tretinoin Gel Microsphere, 0.1%

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

Drug: Tretinoin Gel Microsphere, 0.1%
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other Names:
  • Test Product

    		•
    Active Comparator: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%

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

    Drug: RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
    The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
    Other Names:
  • Reference Product

    		•
    Placebo Comparator: Placebo Control

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

    Drug: Placebo Control
    The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The percentage change in the inflammatory and non-inflammatory lesion counts [Baseline to Week 12]

      Demonstration of Therapeutic Equivalence

    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 ages 12 to 17 years of age, inclusive, must have provided IRB approved written assent

    • Subjects must have a definite clinical diagnosis of acne vulgaris of 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:
    NCT04883736
    Other Study ID Numbers:
    • TRTN-1619
    First Posted:
    May 12, 2021
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 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 May 12, 2021