NCT04856904

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 17 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-02-08
• Completion: 2023-06-30
• First posted: 2021-04-23
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

18 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated drug study