AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Phase 4

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Trifarotene Cream
Drug: Trifarotene Vehicle Cream

Registration Number: NCT05089708

Lead Sponsor: Galderma R&D

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 123

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trifarotene (CD5789) 50 mcg/g Cream	Trifarotene Cream	-
Trifarotene Vehicle Cream	Trifarotene Vehicle Cream	-

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24	Baseline and Week 24	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in PIH ODS Scores at Week 24	Baseline and Week 24	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20	Baseline, at Week 12, Week 16 and Week 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20	Baseline, at Week 12, Week 16 and Week 20	The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.

Trial Locations

Locations (25): Galderma Investigational Site #9950
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Evansville, Indiana, United States
Galderma Investigational Site #8636
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Fountain Valley, California, United States
Galderma Investigational Site #9948
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Hyattsville, Maryland, United States
Galderma Investigational Site #8207
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Nashville, Tennessee, United States
Galderma Investigational Site #7012
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Lutz, Florida, United States
Galderma Investigational Site #9956
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New York, New York, United States
Galderma Investigational Site #8224
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Fremont, California, United States
Galderma Investigational Site #9953
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Tulsa, Oklahoma, United States
Galderma Investigational Site #6192
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Zaragoza, Aragon, Spain
Galderma Investigational Site #9949
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New York, New York, United States
Galderma Investigational Site #8554
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Detroit, Michigan, United States
Galderma Investigational Site #8329
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San Antonio, Texas, United States
Galderma Investigational Site #8358
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San Diego, California, United States
Galderma Investigational Site #9955
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San Diego, California, United States
Galderma Investigational Site #8108
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Las Vegas, Nevada, United States
Galderma Investigational Site #8764
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Tampa, Florida, United States
Galderma Investigational Site #8606
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New Orleans, Louisiana, United States
Galderma Investigational Site #8012
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Glenn Dale, Maryland, United States
Galderma Investigational Site #8620
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New York, New York, United States
Galderma Investigational Site #6278
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Manises, Valencia, Spain
Galderma Investigational Site #6277
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Pontevedra, Spain
Galderma Investigational Site #9920
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Arlington, Texas, United States
Galderma Investigational Site #8433
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San Antonio, Texas, United States
Galderma Investigational Site #8184
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Maitland, Florida, United States
Galderma Investigational Site #9952
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Baton Rouge, Louisiana, United States