AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Study Overview
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Brief Summary
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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

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Trifarotene Cream
* Drug: Trifarotene Vehicle Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trifarotene (CD5789) 50 mcg/g Cream<br> | Drug: Trifarotene Cream<br>* 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<br>* Other names: Aklief;|
| Placebo Comparator: Trifarotene Vehicle Cream<br> | Drug: Trifarotene Vehicle Cream<br>* Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne vulgaris, Trifarotene, Aklief, CD5789