Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation

Phase 4

Completed

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.

Recruitment & Eligibility

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]):
1. Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
2. A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
3. No more than 2 nodules (greater than or equal to [>=] 1 cm in diameter) on the face; and
4. A minimum of 10 atrophic acne scars in total (>2 mm)
Participant with a symmetrical number of the following lesions/scars on the whole face:
1. Inflammatory and non-inflammatory lesions; and
2. 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 also approve for treating acne vulgaris
Other protocol defined inclusion criteria could apply

Key

Exclusion Criteria

Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
Participant with known active or chronic allergies or suspected allergy to trifarotene 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 assessments in the opinion of the investigator
Participant with known impaired hepatic or renal functions, based on medical history

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 Total Atrophic Acne Scar Count Per Half Face at Week 24	Baseline, Week 24	The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20	Baseline, up to Week 20	The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

Locations (18): Galderma Investigational Site #8447
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Fort Smith, Arkansas, United States
Galderma Investigational Site #8608
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Santa Monica, California, United States
Galderma Investigational Site #8881
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Stony Brook, New York, United States
Galderma Investigational Site #8295
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Miami, Florida, United States
Galderma Investigational Site #8108
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Las Vegas, Nevada, United States
Galderma Investigational Site #9920
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Arlington, Texas, United States
Galderma Investigational Site #8873
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Scottsdale, Arizona, United States
Galderma Investigational Site #9928
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Boynton Beach, Florida, United States
Galderma Investigational Site #8367
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Arlington Heights, Illinois, United States
Galderma Investigational Site #8883
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Miramar, Florida, United States
Galderma Investigational Site #8189
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Snellville, Georgia, United States
Galderma Investigational Site #8838
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Darien, Illinois, United States
Galderma Investigational Site #8601
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Metairie, Louisiana, United States
Galderma Investigational Site #9936
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New Orleans, Louisiana, United States
Galderma Investigational Site #8886
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Sugarloaf, Pennsylvania, United States
Galderma Investigational Site #9927
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Saint-Jérôme, Quebec, Canada
Galderma Investigational Site #6167
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Nantes, France
Galderma Investigational Site #9918
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Peterborough, Ontario, Canada