Phase 4
N=123
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT05089708 ↗Enrolled (actual)
123
Serious AEs
0.8%
Results posted
Dec 2023
Primary outcome: Primary: Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 — -2.1; -2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trifarotene Cream (Drug); Trifarotene Vehicle Cream (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24 |
-2.1; -2.1 | — |
| SECONDARY Percent Change From Baseline in PIH ODS Scores at Week 24 |
-45.4; -44.9 | — |
| SECONDARY Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20 |
-1.6; -1.1; -1.9; -1.7; -2.0; -1.9 | — |
| SECONDARY Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20 |
-34.4; -23.6; -41.2; -36.1; -43.9; -41.0 | — |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT05089708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.