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

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

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Trifarotene Vehicle Cream; Drug: Trifarotene Cream

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Peterborough, Ontario, Canada
      • Galderma Investigational Site #9918
  • Quebec
    • Saint-Jérôme, Quebec, Canada
      • Galderma Investigational Site #9927
• France
  • Nantes, France, 44093
    • Galderma Investigational Site #6167
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Galderma Investigational Site #8873
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Galderma Investigational Site #8447
  • California
    • Santa Monica, California, United States, 90404
      • Galderma Investigational Site #8608
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Galderma Investigational Site #9928
    • Miami, Florida, United States, 33136
      • Galderma Investigational Site #8295
    • Miramar, Florida, United States, 33027
      • Galderma Investigational Site #8883
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Galderma Investigational Site #8189
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Galderma Investigational Site #8367
    • Darien, Illinois, United States, 60561
      • Galderma Investigational Site #8838
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Galderma Investigational Site #8601
    • New Orleans, Louisiana, United States, 70130
      • Galderma Investigational Site #9936
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Galderma Investigational Site #8108
  • New York
    • Stony Brook, New York, United States, 11790
      • Galderma Investigational Site #8881
  • Pennsylvania
    • Sugarloaf, Pennsylvania, United States, 18249
      • Galderma Investigational Site #8886
  • Texas
    • Arlington, Texas, United States, 76011
      • Galderma Investigational Site #9920

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trifarotene (CD5789) 50 mcg/g Cream	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; Other Names: AKLIEF®
Placebo Comparator: Trifarotene Vehicle Cream	Drug: 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

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Acne vulgaris; Trifarotene; CD5789; AKLIEF®
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Trifarotene
• Other Study ID Numbers: RD.06.SPR.202395; 2020-006050-51 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No