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Completed

NCT Number: NCT05089708

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Galderma Investigational Site #6192, Zaragoza, Aragon, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participant with clinical diagnosis of acne vulgaris, defined by:
  • moderate acne on the face (acne Investigator's Global Assessment [IGA] =3); and
  • with minimum of 20 inflammatory lesions and 25 non inflammatory lesions on the face (excluding the nose); and
  • moderate to marked PIH on the face (Overview of Pigmentation Disorders hyperpigmentation scale 4-6); and
  • 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

Treatment and study plan

Trifarotene Cream

Drug

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

Trifarotene Vehicle Cream

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: LEAP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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