Trifarotene

(Aklief®)

Aklief®

Drug updated on 9/4/2024

Dosage FormCream (topical; 0.005%)
Drug ClassRetinoids
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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Summary
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  • 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 TitleYearSource
Aklief (trifarotene) Prescribing Information.2019Galderma Laboratories, L.P., Fort Worth, TX

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Guidelines of care for the management of acne vulgaris.2024Journal of the American Academy of Dermatology