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

December 19, 2023 updated by: Galderma R&D

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
Time Frame: Baseline and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in PIH ODS Scores at Week 24
Time Frame: Baseline and 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
Time Frame: Baseline, at Week 12, Week 16 and Week 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
Time Frame: Baseline, at Week 12, Week 16 and Week 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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