AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Last updated: December 19, 2023
Sponsor: Galderma R&D
Overall Status: Completed

Phase

4

Condition

Acne

Rash

Inflammatory Comedones

Treatment

Trifarotene Cream

Trifarotene Vehicle Cream

Clinical Study ID

NCT05089708
RD.06.SPR.204245
2021-003608-41
  • Ages 13-35
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant with clinical diagnosis of acne vulgaris, defined by:
  1. moderate acne on the face (acne Investigator's Global Assessment [IGA] =3); and
  2. with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on theface (excluding the nose); and
  3. moderate to marked PIH on the face (Overview of Pigmentation Disordershyperpigmentation scale 4-6); and
  4. no more than one acne nodule or cyst (greater than [>] 1 centimeter [cm]) on face (excluding the nose)
  • Participant with any Fitzpatrick Skin Type I to VI (target patient enrollmentaccording to FST)
  • Female participants of childbearing potential must have a negative urine pregnancytest (UPT) at Baseline visit
  • Female participants of childbearing potential must agree to use an adequate andapproved method of contraception throughout the study
  • Female participant of non-childbearing potential
  • Other protocol defined inclusion criteria could apply

Exclusion

Key Exclusion Criteria:

  • Participant with severe acne (IGA > 3)
  • Participant with more than 1 nodule/cyst on the face (excluding the nose)
  • Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne,acne requiring systemic treatment
  • Participant with damaged facial skin that may interfere with study assessments
  • Female participant who is pregnant, lactating or planning a pregnancy during the study
  • Female participant of childbearing potential using combined oral contraceptivesapproved as acne treatments, in whom the dose has not been stable for at least 6months prior to the Baseline visit
  • Participant with known impaired hepatic or renal functions
  • Participant with active or chronic skin allergies

Study Design

Total Participants: 123
Treatment Group(s): 2
Primary Treatment: Trifarotene Cream
Phase: 4
Study Start date:
December 22, 2021
Estimated Completion Date:
December 15, 2022

Connect with a study center

  • Galderma Investigational Site #6192

    Zaragoza, Aragon 50009
    Spain

    Site Not Available

  • Galderma Investigational Site #6278

    Manises, Valencia 46940
    Spain

    Site Not Available

  • Galderma Investigational Site #6277

    Pontevedra, 36071
    Spain

    Site Not Available

  • Galderma Investigational Site #8636

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Galderma Investigational Site #8224

    Fremont, California 94538
    United States

    Site Not Available

  • Galderma Investigational Site #8358

    San Diego, California 92108
    United States

    Site Not Available

  • Galderma Investigational Site #9955

    San Diego, California 92123
    United States

    Site Not Available

  • Galderma Investigational Site #7012

    Lutz, Florida 33549
    United States

    Site Not Available

  • Galderma Investigational Site #8184

    Maitland, Florida 32751
    United States

    Site Not Available

  • Galderma Investigational Site #8764

    Tampa, Florida 33613
    United States

    Site Not Available

  • Galderma Investigational Site #9950

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Galderma Investigational Site #9952

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Galderma Investigational Site #8606

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Galderma Investigational Site #8012

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Galderma Investigational Site #9948

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • Galderma Investigational Site #8554

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Galderma Investigational Site #8108

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Galderma Investigational Site #8620

    New York, New York 10025
    United States

    Site Not Available

  • Galderma Investigational Site #9949

    New York, New York 10155
    United States

    Site Not Available

  • Galderma Investigational Site #9956

    New York, New York 10025
    United States

    Site Not Available

  • Galderma Investigational Site #9953

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Galderma Investigational Site #8207

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Galderma Investigational Site #9920

    Arlington, Texas 76011
    United States

    Site Not Available

  • Galderma Investigational Site #8329

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Galderma Investigational Site #8433

    San Antonio, Texas 78229
    United States

    Site Not Available

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