AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
NCT ID: NCT05089708
Last Updated: 2023-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
123 participants
INTERVENTIONAL
2021-12-22
2022-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trifarotene (CD5789) 50 mcg/g Cream
Trifarotene Cream
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
Trifarotene Vehicle Cream
Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Interventions
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Trifarotene Cream
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
Trifarotene Vehicle Cream
Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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
13 Years
35 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Galderma Investigational Site #8636
Fountain Valley, California, United States
Galderma Investigational Site #8224
Fremont, California, United States
Galderma Investigational Site #8358
San Diego, California, United States
Galderma Investigational Site #9955
San Diego, California, United States
Galderma Investigational Site #7012
Lutz, Florida, United States
Galderma Investigational Site #8184
Maitland, Florida, United States
Galderma Investigational Site #8764
Tampa, Florida, United States
Galderma Investigational Site #9950
Evansville, Indiana, United States
Galderma Investigational Site #9952
Baton Rouge, Louisiana, United States
Galderma Investigational Site #8606
New Orleans, Louisiana, United States
Galderma Investigational Site #8012
Glenn Dale, Maryland, United States
Galderma Investigational Site #9948
Hyattsville, Maryland, United States
Galderma Investigational Site #8554
Detroit, Michigan, United States
Galderma Investigational Site #8108
Las Vegas, Nevada, United States
Galderma Investigational Site #8620
New York, New York, United States
Galderma Investigational Site #9956
New York, New York, United States
Galderma Investigational Site #9949
New York, New York, United States
Galderma Investigational Site #9953
Tulsa, Oklahoma, United States
Galderma Investigational Site #8207
Nashville, Tennessee, United States
Galderma Investigational Site #9920
Arlington, Texas, United States
Galderma Investigational Site #8329
San Antonio, Texas, United States
Galderma Investigational Site #8433
San Antonio, Texas, United States
Galderma Investigational Site #6192
Zaragoza, Aragon, Spain
Galderma Investigational Site #6278
Manises, Valencia, Spain
Galderma Investigational Site #6277
Pontevedra, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-003608-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RD.06.SPR.204245
Identifier Type: -
Identifier Source: org_study_id