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
N1 - Publisher Copyright:
© 2019 American Academy of Dermatology, Inc.
PY - 2019/6
Y1 - 2019/6
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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U2 - 10.1016/j.jaad.2019.02.044
DO - 10.1016/j.jaad.2019.02.044
M3 - Article
C2 - 30802558
AN - SCOPUS:85065666909
SN - 0190-9622
VL - 80
SP - 1691
EP - 1699
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 6
ER -