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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Trifarotene Vehicle Cream; Drug: Trifarotene Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856904

2020-006050-51 (EudraCT Number)

RD.06.SPR.202395

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 17 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups, including a placebo group

Trifarotene Vehicle Cream

Placebo Comparator group

Treatment:

Drug: Trifarotene Vehicle Cream

Trifarotene (CD5789) 50 mcg/g Cream

Experimental group

Treatment:

Drug: Trifarotene Cream