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

Study Overview
=================
Brief 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.

Official Title
-----------------
Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Trifarotene Cream
* Drug: Trifarotene Vehicle Cream


Participation Criteria
=================
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]): 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 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

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Trifarotene Vehicle Cream<br> | Drug: Trifarotene Vehicle Cream<br>* Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks<br>|
| Experimental: Trifarotene (CD5789) 50 mcg/g Cream<br> | Drug: Trifarotene Cream<br>* Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks<br>* Other names: AKLIEF®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change from Baseline in Total Atrophic Acne Scar Count Per Half-Face to Week 20 |  | Baseline upto Week 20 | 
| Total Atrophic Acne Scar Count Per Half-Face From Baseline to Week 24 |  | Baseline upto Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne vulgaris, Trifarotene, AKLIEF®, CD5789