Phase
Condition
Rash
Inflammatory Comedones
Scalp Disorders
Treatment
Trifarotene Vehicle Cream
Trifarotene Cream
Clinical Study ID
Ages 17-35 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter [cm]):
Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe),with the same score on both sides of the face; and
A minimum of 20 inflammatory lesions (papules and pustules) in total with atleast 10 on each side; and
No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on theface; and
A minimum of 10 atrophic acne scars in total (>2 mm)
- Participant with a symmetrical number of the following lesions/scars on the wholeface:
Inflammatory and non-inflammatory lesions; and
Atrophic acne scars (minimum of 4 scars per half-face)
The participant is a female of non-childbearing potential
If a female of childbearing, potential uses oral contraceptives that are alsoapprove for treating acne vulgaris
Other protocol defined inclusion criteria could apply
Exclusion
Key Exclusion Criteria:
Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acneand acne requiring systemic treatment
Participant with any acne cyst on the face or with more than 3 excoriated acnelesions
Participant with known active or chronic allergies or suspected allergy totrifarotene or excipients of the formulation
Participant with facial dermal conditions (for example, tattoo, skin abrasion,eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessmentsin the opinion of the investigator
Participant with known impaired hepatic or renal functions, based on medical history
Study Design
Connect with a study center
Galderma Investigational Site #9918
Peterborough, Ontario
CanadaSite Not Available
Galderma Investigational Site #9927
Saint-Jérôme, Quebec
CanadaSite Not Available
Galderma Investigational Site #6167
Nantes, 44093
FranceSite Not Available
Galderma Investigational Site #8873
Scottsdale, Arizona 85260
United StatesSite Not Available
Galderma Investigational Site #8447
Fort Smith, Arkansas 72916
United StatesSite Not Available
Galderma Investigational Site #8608
Santa Monica, California 90404
United StatesSite Not Available
Galderma Investigational Site #9928
Boynton Beach, Florida 33437
United StatesSite Not Available
Galderma Investigational Site #8295
Miami, Florida 33136
United StatesSite Not Available
Galderma Investigational Site #8883
Miramar, Florida 33027
United StatesSite Not Available
Galderma Investigational Site #8189
Snellville, Georgia 30078
United StatesSite Not Available
Galderma Investigational Site #8367
Arlington Heights, Illinois 60005
United StatesSite Not Available
Galderma Investigational Site #8838
Darien, Illinois 60561
United StatesSite Not Available
Galderma Investigational Site #8601
Metairie, Louisiana 70001
United StatesSite Not Available
Galderma Investigational Site #9936
New Orleans, Louisiana 70130
United StatesSite Not Available
Galderma Investigational Site #8108
Las Vegas, Nevada 89148
United StatesSite Not Available
Galderma Investigational Site #8881
Stony Brook, New York 11790
United StatesSite Not Available
Galderma Investigational Site #8886
Sugarloaf, Pennsylvania 18249
United StatesSite Not Available
Galderma Investigational Site #9920
Arlington, Texas 76011
United StatesSite Not Available
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