Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation

Last updated: June 10, 2024
Sponsor: Galderma R&D
Overall Status: Completed

Phase

4

Condition

Rash

Inflammatory Comedones

Scalp Disorders

Treatment

Trifarotene Vehicle Cream

Trifarotene Cream

Clinical Study ID

NCT04856904
RD.06.SPR.202395
2020-006050-51
  • Ages 17-35
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
  1. Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe),with the same score on both sides of the face; and

  2. A minimum of 20 inflammatory lesions (papules and pustules) in total with atleast 10 on each side; and

  3. No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on theface; and

  4. A minimum of 10 atrophic acne scars in total (>2 mm)

  • Participant with a symmetrical number of the following lesions/scars on the wholeface:
  1. Inflammatory and non-inflammatory lesions; and

  2. Atrophic acne scars (minimum of 4 scars per half-face)

  • The participant is a female of non-childbearing potential

  • If a female of childbearing, potential uses oral contraceptives that are alsoapprove for treating acne vulgaris

  • Other protocol defined inclusion criteria could apply

Exclusion

Key Exclusion Criteria:

  • Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acneand acne requiring systemic treatment

  • Participant with any acne cyst on the face or with more than 3 excoriated acnelesions

  • Participant with known active or chronic allergies or suspected allergy totrifarotene or excipients of the formulation

  • Participant with facial dermal conditions (for example, tattoo, skin abrasion,eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessmentsin the opinion of the investigator

  • Participant with known impaired hepatic or renal functions, based on medical history

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: Trifarotene Vehicle Cream
Phase: 4
Study Start date:
May 28, 2021
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Galderma Investigational Site #9918

    Peterborough, Ontario
    Canada

    Site Not Available

  • Galderma Investigational Site #9927

    Saint-Jérôme, Quebec
    Canada

    Site Not Available

  • Galderma Investigational Site #6167

    Nantes, 44093
    France

    Site Not Available

  • Galderma Investigational Site #8873

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Galderma Investigational Site #8447

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Galderma Investigational Site #8608

    Santa Monica, California 90404
    United States

    Site Not Available

  • Galderma Investigational Site #9928

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Galderma Investigational Site #8295

    Miami, Florida 33136
    United States

    Site Not Available

  • Galderma Investigational Site #8883

    Miramar, Florida 33027
    United States

    Site Not Available

  • Galderma Investigational Site #8189

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Galderma Investigational Site #8367

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Galderma Investigational Site #8838

    Darien, Illinois 60561
    United States

    Site Not Available

  • Galderma Investigational Site #8601

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Galderma Investigational Site #9936

    New Orleans, Louisiana 70130
    United States

    Site Not Available

  • Galderma Investigational Site #8108

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Galderma Investigational Site #8881

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Galderma Investigational Site #8886

    Sugarloaf, Pennsylvania 18249
    United States

    Site Not Available

  • Galderma Investigational Site #9920

    Arlington, Texas 76011
    United States

    Site Not Available

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