Vince Bertucci1, Nowell Solish2, Joely Kaufman-Janette3, Steve Yoelin4, Ava Shamban5, Joel Schlessinger6, Daniel Snyder7, Conor Gallagher7, Yan Liu7, Gill Shears8, Roman G Rubio7. 1. Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; private practice, Woodbridge, Ontario, Canada. Electronic address: vince.bertucci@utoronto.ca. 2. Division of Dermatology, University of Toronto, Toronto, Ontario, Canada. 3. Skin Associates of South Florida, Coral Gables, and Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Coral Gables, California. 4. private practice, Newport Beach, California. 5. private practice, Santa Monica, California. 6. Skin Specialists PC, Omaha, California. 7. Revance Therapeutics, Inc, Newark, California. 8. Write on Target Ltd, Leighton Buzzard, United Kingdom.
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.
RCT Entities:
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.
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