Drug updated on 9/4/2024
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
- Aklief (trifarotene) is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Trifarotene 0.005% cream demonstrated effectiveness in treating both facial and truncal acne, with treatment success rates of 65.1% for facial acne (IGA rating) and 66.9% for truncal acne (PGA rating) in a 52-week phase III trial. The overall success rate, defined as success in both IGA and PGA in the same patient, was 57.9%.
- In the adolescent subgroup aged 12-17 with moderate acne, trifarotene showed good clinical efficacy for both facial and truncal acne, with notable improvements in Dermatology Quality of Life Index scores, where 52.8% of patients achieved a score of 0 or 1 after treatment compared to 22.6% at baseline.
- Trifarotene was generally well tolerated, with common adverse effects reported being pruritus, irritation, and sunburn. No severe safety concerns were highlighted in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aklief (trifarotene) Prescribing Information. | 2019 | Galderma Laboratories, L.P., Fort Worth, TX |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
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 |