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

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ClinicalTrials.gov Identifier: NCT05089708
Recruitment Status : Completed
First Posted : October 22, 2021
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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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
Acne Vulgaris Drug: Trifarotene Cream Drug: Trifarotene Vehicle Cream Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 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 : December 27, 2021
Actual Primary Completion Date : December 15, 2022
Actual Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Trifarotene

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity Scores at Week 24 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05089708


Locations
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Sponsors and Collaborators
Galderma R&D
More Information
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT05089708    
Other Study ID Numbers: RD.06.SPR.204245
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022

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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:
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Acne Vulgaris
Hyperpigmentation
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Pigmentation Disorders
Trifarotene
Dermatologic Agents