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

Sponsor
Galderma R&D (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04856904
Collaborator
(none)
118
18
2
20.6
6.6
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trifarotene Cream
  • Drug: Trifarotene Vehicle Cream
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
Actual Study Start Date :
May 28, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Trifarotene Vehicle Cream

Drug: Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks

Experimental: Trifarotene (CD5789) 50 mcg/g Cream

Drug: Trifarotene Cream
Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks
Other Names:
  • AKLIEF®
  • Outcome Measures

    Primary Outcome Measures

    1. Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24 [Baseline, Week 24]

    Secondary Outcome Measures

    1. Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half-Face to Week 20 [Baseline upto Week 20]

    2. Total Atrophic Acne Scar Count Per Half-Face From Baseline to Week 24 [Baseline upto Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 at least 10 on each side; and

    3. No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; 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 whole face:
    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 also approve for treating acne vulgaris

    • Other protocol defined inclusion criteria could apply

    Key Exclusion Criteria:
    • Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment

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

    • Participant with known active or chronic allergies or suspected allergy to trifarotene 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 assessments in the opinion of the investigator

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Galderma Investigational Site #8873 Scottsdale Arizona United States 85260
    2 Galderma Investigational Site #8447 Fort Smith Arkansas United States 72916
    3 Galderma Investigational Site #8608 Santa Monica California United States 90404
    4 Galderma Investigational Site #9928 Boynton Beach Florida United States 33437
    5 Galderma Investigational Site #8295 Miami Florida United States 33136
    6 Galderma Investigational Site #8883 Miramar Florida United States 33027
    7 Galderma Investigational Site #8189 Snellville Georgia United States 30078
    8 Galderma Investigational Site #8367 Arlington Heights Illinois United States 60005
    9 Galderma Investigational Site #8838 Darien Illinois United States 60561
    10 Galderma Investigational Site #8601 Metairie Louisiana United States 70001
    11 Galderma Investigational Site #9936 New Orleans Louisiana United States 70130
    12 Galderma Investigational Site #8108 Las Vegas Nevada United States 89148
    13 Galderma Investigational Site #8881 Stony Brook New York United States 11790
    14 Galderma Investigational Site #8886 Sugarloaf Pennsylvania United States 18249
    15 Galderma Investigational Site #9920 Arlington Texas United States 76011
    16 Galderma Investigational Site #9918 Peterborough Ontario Canada
    17 Galderma Investigational Site #9927 Saint-Jérôme Quebec Canada
    18 Galderma Investigational Site #6167 Nantes France 44093

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT04856904
    Other Study ID Numbers:
    • RD.06.SPR.202395
    • 2020-006050-51
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Galderma R&D
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 21, 2022