Trifarotene

(Aklief®)

Aklief®

Drug updated on 10/29/2024

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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  • 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: -11.5, 95% CI (confidence interval): -14.39 to -8.62) and non-inflammatory lesion count (Mean Difference: -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 TitleYearSource
Aklief (trifarotene) Prescribing Information.2023Galderma Laboratories, L.P., Fort Worth, TX

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Guidelines of care for the management of acne vulgaris2024Journal of the American Academy of Dermatology