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

Phase 4 Completed 121 enrolled Galderma R&D

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-05-28
Primary completion: 2023-02-08
Completion: 2023-06-30

Outcome

Met primary endpoint

registry analysis (superiority test); Trifarotene 50mcg/g Cream vs Trifarotene Vehicle Cream; p < 0.0001; Bilateral difference -3.2 (95% CI -4.4 to -2) NCT04856904 ↗

Publications

Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, Chavda R, York JP, Sforzolini B, Holcomb K, Ablon G, Del Rosso J, Dreno B. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study. Dermatol Ther (Heidelb). 2023 Dec;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7. Epub 2023 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trifarotene	Small molecule	50 unknown	Topical