AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (LEAP)

Evaluation of Acne-induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Trifarotene Cream; Drug: Trifarotene Vehicle Cream

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36071
    • Galderma Investigational Site #6277
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Galderma Investigational Site #6192
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Galderma Investigational Site #6278
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Galderma Investigational Site #8636
    • Fremont, California, United States, 94538
      • Galderma Investigational Site #8224
    • San Diego, California, United States, 92108
      • Galderma Investigational Site #8358
    • San Diego, California, United States, 92123
      • Galderma Investigational Site #9955
  • Florida
    • Lutz, Florida, United States, 33549
      • Galderma Investigational Site #7012
    • Maitland, Florida, United States, 32751
      • Galderma Investigational Site #8184
    • Tampa, Florida, United States, 33613
      • Galderma Investigational Site #8764
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Galderma Investigational Site #9950
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Galderma Investigational Site #9952
    • New Orleans, Louisiana, United States, 70115
      • Galderma Investigational Site #8606
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Galderma Investigational Site #8012
    • Hyattsville, Maryland, United States, 20782
      • Galderma Investigational Site #9948
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Galderma Investigational Site #8554
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Galderma Investigational Site #8108
  • New York
    • New York, New York, United States, 10025
      • Galderma Investigational Site #8620
    • New York, New York, United States, 10025
      • Galderma Investigational Site #9956
    • New York, New York, United States, 10155
      • Galderma Investigational Site #9949
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Galderma Investigational Site #9953
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Galderma Investigational Site #8207
  • Texas
    • Arlington, Texas, United States, 76011
      • Galderma Investigational Site #9920
    • San Antonio, Texas, United States, 78229
      • Galderma Investigational Site #8329
    • San Antonio, Texas, United States, 78229
      • Galderma Investigational Site #8433

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but <mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in PIH ODS Scores at Week 24	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but <mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.	Baseline and Week 24
Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but <mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.	Baseline, at Week 12, Week 16 and Week 20
Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but <mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.	Baseline, at Week 12, Week 16 and Week 20

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acne vulgaris; Trifarotene; Aklief; CD5789
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Pigmentation Disorders; Acne Vulgaris; Hyperpigmentation; Dermatologic Agents; Trifarotene
• Other Study ID Numbers: RD.06.SPR.204245; 2021-003608-41 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No