Status:
COMPLETED
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
17-35 years
Phase:
PHASE4
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 wee...
Eligibility Criteria
Inclusion
- Key
- 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 at least 10 on each side; and
- No more than 2 nodules (greater than or equal to \[\>=\] 1 cm in diameter) on the face; and
- 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:
- 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 also approve for treating acne vulgaris
- Other protocol defined inclusion criteria could apply
- Key
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04856904
Start Date
May 28 2021
End Date
June 30 2023
Last Update
June 11 2024
Active Locations (18)
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1
Galderma Investigational Site #8873
Scottsdale, Arizona, United States, 85260
2
Galderma Investigational Site #8447
Fort Smith, Arkansas, United States, 72916
3
Galderma Investigational Site #8608
Santa Monica, California, United States, 90404
4
Galderma Investigational Site #9928
Boynton Beach, Florida, United States, 33437