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

U. Blume-Peytavi, J. Fowler, L. Kemény, Z. Draelos, F. Cook-Bolden, T. Dirschka, L. Eichenfield, M. Graeber, F. Ahmad, A. Alió Saenz, P. Rich, E. Tanghetti

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalJournal of the European Academy of Dermatology and Venereology
DOIs
Publication statusAccepted/In press - Jan 1 2019

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Retinoids
Acne Vulgaris
Safety
Prostaglandins A
Quality of Life
Signs and Symptoms
Therapeutics
Research Personnel
Physicians
Skin

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

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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. / 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.

In: Journal of the European Academy of Dermatology and Venereology, 01.01.2019.

Research output: Contribution to journalArticle

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. / 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. In: Journal of the European Academy of Dermatology and Venereology. 2019.
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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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T1 - 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

AU - Blume-Peytavi, U.

AU - Fowler, J.

AU - Kemény, L.

AU - Draelos, Z.

AU - Cook-Bolden, F.

AU - Dirschka, T.

AU - Eichenfield, L.

AU - Graeber, M.

AU - Ahmad, F.

AU - Alió Saenz, A.

AU - Rich, P.

AU - Tanghetti, E.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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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