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

Acne Vulgaris Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856904
• Other study ID #: RD.06.SPR.202395
• Secondary ID: 2020-006050-51
• Status: Completed
• Phase: Phase 4
• Start date: May 28, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 30, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Canada	Galderma Investigational Site #9918	Peterborough	Ontario
Canada	Galderma Investigational Site #9927	Saint-Jérôme	Quebec
France	Galderma Investigational Site #6167	Nantes
United States	Galderma Investigational Site #9920	Arlington	Texas
United States	Galderma Investigational Site #8367	Arlington Heights	Illinois
United States	Galderma Investigational Site #9928	Boynton Beach	Florida
United States	Galderma Investigational Site #8838	Darien	Illinois
United States	Galderma Investigational Site #8447	Fort Smith	Arkansas
United States	Galderma Investigational Site #8108	Las Vegas	Nevada
United States	Galderma Investigational Site #8601	Metairie	Louisiana
United States	Galderma Investigational Site #8295	Miami	Florida
United States	Galderma Investigational Site #8883	Miramar	Florida
United States	Galderma Investigational Site #9936	New Orleans	Louisiana
United States	Galderma Investigational Site #8608	Santa Monica	California
United States	Galderma Investigational Site #8873	Scottsdale	Arizona
United States	Galderma Investigational Site #8189	Snellville	Georgia
United States	Galderma Investigational Site #8881	Stony Brook	New York
United States	Galderma Investigational Site #8886	Sugarloaf	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 24
Secondary	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.	Baseline, up to Week 20