AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris; Hyperpigmentation
Intervention: Trifarotene Cream; Trifarotene Vehicle Cream
Intervention description: 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; Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Intervention MeSH terms: Trifarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 13 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Acne vulgaris; Trifarotene; Aklief; CD5789

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
      vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks
      of treatment in facial acne participants
    

Eligibility 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
                  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