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

Launched by GALDERMA R&D · Apr 20, 2021

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Gender

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Eligibility 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