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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    118
  • sponsor
    Galderma R&D
Updated on 4 August 2021

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.

Details
Condition Acne Vulgaris, Acne, acnes
Treatment Trifarotene Cream, Trifarotene Vehicle Cream
Clinical Study IdentifierNCT04856904
SponsorGalderma R&D
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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])
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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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