Skip to main content
OpenTrials
Completed

NCT Number: NCT04856904

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

17 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Galderma Investigational Site #9918, Peterborough, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trifarotene Cream

Drug

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®

Trifarotene Vehicle Cream

Drug

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Acronym: START

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.