Drug updated on 12/11/2024
Dosage Form | Cream (topical; 0.005%) |
Drug Class | Retinoids |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Trifarotene significantly reduced inflammatory lesion count (mean difference (MD): -11.5, 95% confidence interval (CI): -14.39 to -8.62) and non-inflammatory lesion count (MD: -12.25, 95% CI: -15.21 to -9.29), with a treatment success rate of 65.1% for facial acne and 66.9% for truncal acne in a 52-week Phase III (Investigator Global Assessment (IGA) rating of no or almost no acne) trial.
- In patients aged 12-17 with moderate acne, trifarotene was effective on both the face and trunk, with no significant differences in efficacy compared to clascoterone and tazarotene after 12 weeks of treatment.
- Overall treatment success rate was 57.9%, with improvements in quality of life (52.8% of patients achieving a Dermatology Quality of Life Index score of 0 or 1, compared to 22.6% at baseline).
- Trifarotene was well tolerated, with a low and acceptable rate of adverse events in two Phase 3 pivotal trials. Common adverse effects included pruritus, irritation, and sunburn.
- Differences in safety profiles between trifarotene, clascoterone, and tazarotene were suggested, though specific safety outcomes were not detailed in the systematic review.
- There is no specific subgroup information available beyond the age group of 12-17 years in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aklief (trifarotene) Prescribing Information. | 2023 | Galderma Laboratories, L.P., Fort Worth, TX |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Comparison of the Efficacy of Clascoterone, Trifarotene, and Tazarotene for the Treatment of Acne: A Systematic Literature Review and Meta-Analysis | 2024 | Dermatology and Therapy |
Advances in Topical Management of Adolescent Facial and Truncal Acne: A Phase 3 Pooled Analysis of Safety and Efficacy of Trifarotene 0.005% Cream | 2022 | Journal of Drugs in Dermatology |
Trifarotene for the Treatment of Facial and Truncal Acne | 2021 | The Annals of Pharmacotherapy |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Guidelines of care for the management of acne vulgaris | 2024 | Journal of the American Academy of Dermatology |