NCT05089708

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Evaluation of Acne-induced Hyperpigmentation 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: 123 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 13 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Trifarotene Cream	Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on 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 on the face once daily, in the evening for 24 weeks

Timeline

• Start date: 2021-12-22
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-10-22
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

25 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study