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Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne.

  • Author(s): Blume-Peytavi, U;
  • Fowler, J;
  • Kemény, L;
  • Draelos, Z;
  • Cook-Bolden, F;
  • Dirschka, T;
  • Eichenfield, L;
  • Graeber, M;
  • Ahmad, F;
  • Alió Saenz, A;
  • Rich, P;
  • Tanghetti, E
  • et al.

Published Web Location

https://doi.org/10.1111/jdv.15794
Abstract

Background

Treatment for both facial and truncal acne has not sufficiently been studied.

Objectives

To evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.

Methods

In a multicentre, open-label, 52-week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET.

Results

Of 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene-related treatment-emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter. At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52. At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit.

Conclusion

In this 52-week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.

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