Clinical trial NCT05089708: AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
Official title: Evaluation of Acne-induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Trifarotene
Aklief
CD5789
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 123
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percent Change From Baseline in PIH ODS Scores at Week 24
timeFrame: Baseline and Week 24
measure: Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
timeFrame: Baseline, at Week 12, Week 16 and Week 20
measure: Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20
timeFrame: Baseline, at Week 12, Week 16 and Week 20
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Galderma Investigational Site #8636
state: California
city: Fremont
country: United States
facility: Galderma Investigational Site #8224
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site #8358
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site #9955
state: California
city: Lutz
country: United States
facility: Galderma Investigational Site #7012
state: Florida
city: Maitland
country: United States
facility: Galderma Investigational Site #8184
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site #8764
state: Florida
city: Evansville
country: United States
facility: Galderma Investigational Site #9950
state: Indiana
city: Baton Rouge
country: United States
facility: Galderma Investigational Site #9952
state: Louisiana
city: New Orleans
country: United States
facility: Galderma Investigational Site #8606
state: Louisiana
city: Glenn Dale
country: United States
facility: Galderma Investigational Site #8012
state: Maryland
city: Hyattsville
country: United States
facility: Galderma Investigational Site #9948
state: Maryland
city: Detroit
country: United States
facility: Galderma Investigational Site #8554
state: Michigan
city: Las Vegas
country: United States
facility: Galderma Investigational Site #8108
state: Nevada
city: New York
country: United States
facility: Galderma Investigational Site #8620
state: New York
city: New York
country: United States
facility: Galderma Investigational Site #9956
state: New York
city: New York
country: United States
facility: Galderma Investigational Site #9949
state: New York
city: Tulsa
country: United States
facility: Galderma Investigational Site #9953
state: Oklahoma
city: Nashville
country: United States
facility: Galderma Investigational Site #8207
state: Tennessee
city: Arlington
country: United States
facility: Galderma Investigational Site #9920
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site #8329
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site #8433
state: Texas
city: Zaragoza
country: Spain
facility: Galderma Investigational Site #6192
state: Aragon
city: Manises
country: Spain
facility: Galderma Investigational Site #6278
state: Valencia
city: Pontevedra
country: Spain
facility: Galderma Investigational Site #6277
Study officials:
References: