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.
To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.
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).
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%).
The study population was predominantly female and white and received only a single treatment.
DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.Le texte complet de cet article est disponible en PDF.
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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.