Phase
Condition
Acne
Rash
Inflammatory Comedones
Treatment
Trifarotene Cream
Trifarotene Vehicle Cream
Clinical Study ID
Ages 13-35 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theface (excluding the nose); and
- moderate to marked PIH on the face (Overview of Pigmentation Disordershyperpigmentation 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 enrollmentaccording to FST)
- Female participants of childbearing potential must have a negative urine pregnancytest (UPT) at Baseline visit
- Female participants of childbearing potential must agree to use an adequate andapproved method of contraception throughout the study
- Female participant of non-childbearing potential
- Other protocol defined inclusion criteria could apply
Exclusion
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 contraceptivesapproved as acne treatments, in whom the dose has not been stable for at least 6months prior to the Baseline visit
- Participant with known impaired hepatic or renal functions
- Participant with active or chronic skin allergies
Study Design
Connect with a study center
Galderma Investigational Site #6192
Zaragoza, Aragon 50009
SpainSite Not Available
Galderma Investigational Site #6278
Manises, Valencia 46940
SpainSite Not Available
Galderma Investigational Site #6277
Pontevedra, 36071
SpainSite Not Available
Galderma Investigational Site #8636
Fountain Valley, California 92708
United StatesSite Not Available
Galderma Investigational Site #8224
Fremont, California 94538
United StatesSite Not Available
Galderma Investigational Site #8358
San Diego, California 92108
United StatesSite Not Available
Galderma Investigational Site #9955
San Diego, California 92123
United StatesSite Not Available
Galderma Investigational Site #7012
Lutz, Florida 33549
United StatesSite Not Available
Galderma Investigational Site #8184
Maitland, Florida 32751
United StatesSite Not Available
Galderma Investigational Site #8764
Tampa, Florida 33613
United StatesSite Not Available
Galderma Investigational Site #9950
Evansville, Indiana 47714
United StatesSite Not Available
Galderma Investigational Site #9952
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Galderma Investigational Site #8606
New Orleans, Louisiana 70115
United StatesSite Not Available
Galderma Investigational Site #8012
Glenn Dale, Maryland 20769
United StatesSite Not Available
Galderma Investigational Site #9948
Hyattsville, Maryland 20782
United StatesSite Not Available
Galderma Investigational Site #8554
Detroit, Michigan 48202
United StatesSite Not Available
Galderma Investigational Site #8108
Las Vegas, Nevada 89148
United StatesSite Not Available
Galderma Investigational Site #8620
New York, New York 10025
United StatesSite Not Available
Galderma Investigational Site #9949
New York, New York 10155
United StatesSite Not Available
Galderma Investigational Site #9956
New York, New York 10025
United StatesSite Not Available
Galderma Investigational Site #9953
Tulsa, Oklahoma 74133
United StatesSite Not Available
Galderma Investigational Site #8207
Nashville, Tennessee 37215
United StatesSite Not Available
Galderma Investigational Site #9920
Arlington, Texas 76011
United StatesSite Not Available
Galderma Investigational Site #8329
San Antonio, Texas 78229
United StatesSite Not Available
Galderma Investigational Site #8433
San Antonio, Texas 78229
United StatesSite Not Available
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