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 andSAKURA 2)

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:82

Article

Bertucci, Vince¹  Solish, Nowell¹  Kaufman-Janette, Joely^2,3  Schlessinger, Joel⁴  Snyder, Daniel⁵  Gallagher, Conor⁵  Liu, Yan⁵  Shears, Gill⁶  Rubio, Roman G.⁵ 

[1] Univ Toronto, Div Dermatol, Toronto, ON, Canada

[2] Skin Associates South Florida, Coral Gables, FL USA

[3] Univ Miami, Miller Sch Med, Dept Dermatol & Cutaneous Surg, Miami, FL 33136 USA

[4] Skin Specialists PC, Omaha, NE USA

[5] Revance Therapeut Inc, Newark, CA USA

[6] Write Target Ltd, Leighton Buzzard, England

关键词: 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;   

DOI  :  10.1016/j.jaad.2019.06.1313

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

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