Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne

Jerry Tan, Diane Thiboutot, Georg Popp, Melinda Gooderham, Charles Lynde, James Del Rosso, Jonathan Weiss, Ulrike Blume-Peytavi, Jolanta Weglovska, Sandra Johnson, Lawrence Parish, Dagmara Witkowska, Nestor Sanchez Colon, Alessandra Alió Saenz, Faiz Ahmad, Michael Graeber, Linda Stein Gold

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Objectives: Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Methods: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. Results: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. Limitations: Adjunctive topical or systemic treatments were not studied. Conclusion: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.

Original languageEnglish (US)
Pages (from-to)1691-1699
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume80
Issue number6
DOIs
StatePublished - Jun 1 2019

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Acne Vulgaris
Research Personnel
Safety
Vital Signs
Retinoids
Therapeutics
Thorax
Physicians

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

Tan, Jerry ; Thiboutot, Diane ; Popp, Georg ; Gooderham, Melinda ; Lynde, Charles ; Del Rosso, James ; Weiss, Jonathan ; Blume-Peytavi, Ulrike ; Weglovska, Jolanta ; Johnson, Sandra ; Parish, Lawrence ; Witkowska, Dagmara ; Sanchez Colon, Nestor ; Alió Saenz, Alessandra ; Ahmad, Faiz ; Graeber, Michael ; Stein Gold, Linda. / Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. In: Journal of the American Academy of Dermatology. 2019 ; Vol. 80, No. 6. pp. 1691-1699.
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title = "Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne",
abstract = "Background: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Objectives: Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Methods: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. Results: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. Limitations: Adjunctive topical or systemic treatments were not studied. Conclusion: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.",
author = "Jerry Tan and Diane Thiboutot and Georg Popp and Melinda Gooderham and Charles Lynde and {Del Rosso}, James and Jonathan Weiss and Ulrike Blume-Peytavi and Jolanta Weglovska and Sandra Johnson and Lawrence Parish and Dagmara Witkowska and {Sanchez Colon}, Nestor and {Ali{\'o} Saenz}, Alessandra and Faiz Ahmad and Michael Graeber and {Stein Gold}, Linda",
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Tan, J, Thiboutot, D, Popp, G, Gooderham, M, Lynde, C, Del Rosso, J, Weiss, J, Blume-Peytavi, U, Weglovska, J, Johnson, S, Parish, L, Witkowska, D, Sanchez Colon, N, Alió Saenz, A, Ahmad, F, Graeber, M & Stein Gold, L 2019, 'Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne', Journal of the American Academy of Dermatology, vol. 80, no. 6, pp. 1691-1699. https://doi.org/10.1016/j.jaad.2019.02.044

Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. / Tan, Jerry; Thiboutot, Diane; Popp, Georg; Gooderham, Melinda; Lynde, Charles; Del Rosso, James; Weiss, Jonathan; Blume-Peytavi, Ulrike; Weglovska, Jolanta; Johnson, Sandra; Parish, Lawrence; Witkowska, Dagmara; Sanchez Colon, Nestor; Alió Saenz, Alessandra; Ahmad, Faiz; Graeber, Michael; Stein Gold, Linda.

In: Journal of the American Academy of Dermatology, Vol. 80, No. 6, 01.06.2019, p. 1691-1699.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne

AU - Tan, Jerry

AU - Thiboutot, Diane

AU - Popp, Georg

AU - Gooderham, Melinda

AU - Lynde, Charles

AU - Del Rosso, James

AU - Weiss, Jonathan

AU - Blume-Peytavi, Ulrike

AU - Weglovska, Jolanta

AU - Johnson, Sandra

AU - Parish, Lawrence

AU - Witkowska, Dagmara

AU - Sanchez Colon, Nestor

AU - Alió Saenz, Alessandra

AU - Ahmad, Faiz

AU - Graeber, Michael

AU - Stein Gold, Linda

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Background: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Objectives: Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Methods: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. Results: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. Limitations: Adjunctive topical or systemic treatments were not studied. Conclusion: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.

AB - Background: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied. Objectives: Assess the safety and efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne. Methods: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results. Results: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle. Limitations: Adjunctive topical or systemic treatments were not studied. Conclusion: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.

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JO - Journal of the American Academy of Dermatology

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