AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Trifarotene

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