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

Galderma R&D121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

121

Conditions

Acne Vulgaris

Interventions

Trifarotene CreamDRUG

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

Trifarotene Vehicle CreamDRUG

Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks

Eligibility

Sex: ALLMin age: 17 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (18)

Galderma Investigational Site #8873

Scottsdale, Arizona, United States

Galderma Investigational Site #8447

Fort Smith, Arkansas, United States

Outcomes

Primary Outcomes

Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half Face at Week 24

The scars were counted according to their size defined in two categories using 2 millimeter (mm) and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

Time frame: Baseline, Week 24

Secondary Outcomes

Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20

The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

Time frame: Baseline, up to Week 20

Data from ClinicalTrials.gov

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