AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

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

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