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

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Trifarotene

Criteria

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]):

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