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

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Trifarotene, AKLIEF®, CD5789 Read More

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