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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 Locationhttps://doi.org/10.1111/jdv.15794
BackgroundTreatment for both facial and truncal acne has not sufficiently been studied.
ObjectivesTo evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.
MethodsIn 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.
ResultsOf 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.
ConclusionIn this 52-week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.
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