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LEAP: AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Sponsor
Galderma R&D (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05089708
Collaborator
(none)
120
Enrollment
25
Locations
2
Arms
16.1
Anticipated Duration (Months)
4.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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 vulagris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Acne-induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
Actual Study Start Date :
Dec 27, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trifarotene (CD5789) 50 mcg/g Cream

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

    		•
    Placebo Comparator: Trifarotene Vehicle Cream

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

    Outcome Measures

    Primary Outcome Measures

    1. Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity Scores at Week 24 [Baseline, Week 24]

      PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

    Secondary Outcome Measures

    1. Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 24 [Baseline upto Week 24]

      PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

    2. Absolute Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20 [Baseline, Week 12, Week 16 and Week 20]

      PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

    3. Percent Change From Baseline in PIH Overall Disease Severity Scores at Week 12, 16 and 20 [Baseline, Week 12, Week 16 and Week 20]

      PIH improvement assessment was based on a 7-point Likert scale ranging from -3 (much darker) to 3 (much lighter), higher score = improvement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 the face (excluding the nose); and

    3. moderate to marked PIH on the face (Overview of Pigmentation Disorders [ODS] hyperpigmentation 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 enrollment according to FST)

    • Female participants of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit

    • Female participants of childbearing potential must agree to use an adequate and approved method of contraception throughout the study

    • Female participant of non-childbearing potential

    • Other protocol defined inclusion criteria could apply

    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 contraceptives approved as acne treatments, in whom the dose has not been stable for at least 6 months prior to the Baseline visit

    • Participant with known impaired hepatic or renal functions

    • Participant with active or chronic skin allergies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Galderma Investigational Site #8636 Fountain Valley California United States 92708
    2 Galderma Investigational Site #8224 Fremont California United States 94538
    3 Galderma Investigational Site #8358 San Diego California United States 92108
    4 Galderma Investigational Site #9955 San Diego California United States 92123
    5 Galderma Investigational Site #7012 Lutz Florida United States 33549
    6 Galderma Investigational Site #8184 Maitland Florida United States 32751
    7 Galderma Investigational Site #8764 Tampa Florida United States 33613
    8 Galderma Investigational Site #9950 Evansville Indiana United States 47714
    9 Galderma Investigational Site #9952 Baton Rouge Louisiana United States 70808
    10 Galderma Investigational Site #8606 New Orleans Louisiana United States 70115
    11 Galderma Investigational Site #8012 Glenn Dale Maryland United States 20769
    12 Galderma Investigational Site #9948 Hyattsville Maryland United States 20782
    13 Galderma Investigational Site #8554 Detroit Michigan United States 48202
    14 Galderma Investigational Site #8108 Las Vegas Nevada United States 89148
    15 Galderma Investigational Site #8620 New York New York United States 10025
    16 Galderma Investigational Site #9956 New York New York United States 10025
    17 Galderma Investigational Site #9949 New York New York United States 10155
    18 Galderma Investigational Site #9953 Tulsa Oklahoma United States 74133
    19 Galderma Investigational Site #8207 Nashville Tennessee United States 37215
    20 Galderma Investigational Site #9920 Arlington Texas United States 76011
    21 Galderma Investigational Site #8329 San Antonio Texas United States 78229
    22 Galderma Investigational Site #8433 San Antonio Texas United States 78229
    23 Galderma Investigational Site #6192 Zaragoza Aragon Spain 50009
    24 Galderma Investigational Site #6278 Manises Valencia Spain 46940
    25 Galderma Investigational Site #6277 Pontevedra Spain 36071

    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:
    NCT05089708
    Other Study ID Numbers:
    • RD.06.SPR.204245
    First Posted:
    Oct 22, 2021
    Last Update Posted:
    Jul 29, 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
    Acne vulgaris
    Trifarotene
    Aklief
    CD5789
    Additional relevant MeSH terms:
    Acne Vulgaris
    Hyperpigmentation
    Trifarotene

    Study Results

    No Results Posted as of Jul 29, 2022