AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (LEAP)

Galderma

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Trifarotene Vehicle Cream

Drug: Trifarotene Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05089708

RD.06.SPR.204245

2021-003608-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

123 patients

Sex

All

Ages

13 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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