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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le vendredi 29 novembre 2019
Doi : 10.1016/j.jaad.2019.06.1313
accepted : 8 June 2019
DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)
 

Vince Bertucci, MD a, b, , Nowell Solish, MD a, Joely Kaufman-Janette, MD c, Steve Yoelin, MD d, Ava Shamban, MD e, Joel Schlessinger, MD f, Daniel Snyder, PhD g, Conor Gallagher, PhD g, Yan Liu, MSc g, Gill Shears, PhD h, Roman G. Rubio, MD g
a Division of Dermatology, University of Toronto, Toronto, Ontario, Canada 
b private practice, Woodbridge, Ontario, Canada 
c Skin Associates of South Florida, Coral Gables, and Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Coral Gables, California 
d private practice, Newport Beach, California 
e private practice, Santa Monica, California 
f Skin Specialists PC, Omaha, California 
g Revance Therapeutics, Inc, Newark, California 
h Write on Target Ltd, Leighton Buzzard, United Kingdom 

Reprint requests: Vince Bertucci, MD, 8333 Weston Rd, Ste 100, Woodbridge, ON L4L 8E2, Canada.8333 Weston Rd, Ste 100WoodbridgeONL4L 8E2Canada
Abstract
Background

DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.

Objective

To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.

Methods

Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks).

Results

Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated—treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).

Limitations

The study population was predominantly female and white and received only a single treatment.

Conclusions

DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.

The full text of this article is available in PDF format.
Graphical abstract




The full text of this article is available in PDF format.

Key words : aesthetic, botulinum toxin, DAXI, daxibotulinumtoxinA, double-blind, duration, facial rejuvenation, glabellar lines, humans, injection, multicenter, neuromodulator, neuromuscular agent, peptide, phase 3, placebo, pooled, randomized, RT002, RTP004

Abbreviations used : BoNTA, GAIS, IGA-FWS, PFWS, US FDA



 Funding sources: Studies and manuscript development funded by Revance Therapeutics, Inc.
 Conflicts of interest: Dr Bertucci has been an investigator and consultant for Evolus, and a speaker, investigator, and consultant for Allergan, Galderma, Merz, and Revance Therapeutics, Inc. Dr Solish has been a consultant and/or speaker for Allergan, Revance Therapeutics, Inc, and Galderma. Dr Kaufman-Janette has been an advisory board participant for Revance Therapeutics, Inc, and declares ownership of a company with a patent for botulinum toxin in wound healing. Dr Yoelin has received research honoraria, consultant fees, and speaker fees from Allergan and has received research honoraria and consultant fees from Revance Therapeutics, Inc. Dr Shamban has received research honoraria, speaker fees, and/or consultant fees from Merz, Allergan, and Galderma. Dr Schlessinger is an adviser to, and owns shares in, Revance Therapeutics, Inc. Authors Snyder, Gallagher, Liu, and Rubio are employees of, and hold stock/stock options in, Revance Therapeutics, Inc. Dr Shears is an employee of, and holds stock in, Write on Target Ltd.
 Some of the data have previously been presented at the 20th Annual International Master Course on Aging Skin World Congress, Paris, France, February 1-3, 2018; at The Aesthetic Meeting 2018, New York, NY, April 26-May 1, 2018; and at the 77th Annual Meeting of the American Academy of Dermatology, Washington, DC, March 1-5, 2019.



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