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New Published Data Supports the Safety and Efficacy of LetibotulinumtoxinA for the Treatment of Glabellar Lines

July 27, 2022 Off By BusinessWire

First Peer-Reviewed Publication from BLESS Phase 3 Program in Aesthetic Surgery Journal

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–Hugel Aesthetics announces the publication of the BLESS III clinical trial in the Aesthetic Surgery Journal. The published data comes as Hugel is accelerating its efforts towards becoming a leading global medical aesthetics company.

“Millions of people around the world trust Hugel’s quality botulinum toxin,” said James Hartman, President of Hugel Aesthetics. “We are thankful to the investigators who participated in this clinical study and are pleased the data are now available in such a prestigious aesthetics journal.”

LetibotulinumtoxinA safety and efficacy were evaluated in a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial of subjects with moderate-to-severe glabellar lines. A total of 355 female and male subjects between the ages of 18 and 75 were enrolled in this study and treated with 20 U letibotulinumtoxinA or placebo:

  • The primary endpoint of the study was met: 64.7% of letibotulinumtoxinA subjects were at least 2-point Facial Wrinkle Scale (FWS) composite responders compared to 0.0% of placebo subjects at Week 4 (p<0.001). 1
  • Ninety-four percent (94.0%) and 89.1% of letibotulinumtoxinA subjects were at least 1-point FWS responders at Week 4 based on investigator and subject assessments, respectively. 1
  • Based on the subjects’ daily diary data, the median time to onset was three days; 24% of the letibotulinumtoxinA subjects reported at least a 1-point reduction in FWS within 24 hours of treatment.1
  • LetibotulinumtoxinA was well-tolerated with a low incidence of treatment-emergent adverse events (TEAEs). Headache was the most common related TEAE, occurring in 1.1% of letibotulinumtoxinA subjects and 0.0% of placebo subjects during the double-blind phase of the study. 1

Hugel has sold over 21 million vials globally of its botulinum toxin type A and has been the market leader for six consecutive years in South Korea, one of the world’s most dynamic aesthetic markets. The product is now available in 41 countries.

References:

  1. Mueller DS, Prinz V, Adelglass J, Cox SE, Gold M, Kaufman-Janette J et al. Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study. Aesthet Surg J. 2022; 42(6): 677- 88.

About Hugel America, Inc. (Hugel Aesthetics)

Hugel America, Inc. (Hugel Aesthetics) is a growth-focused joint venture between aesthetic marketing leading partners, Hugel, Inc and Croma-Pharma GmbH, focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, Australia, and New Zealand.

The Hugel Aesthetics application for letibotulinumtoxinA for the treatment of glabellar lines is currently under review by the U.S. Food and Drug Administration.

Hugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: www.hugel-aesthetics.com

Contacts

Kayleigh Adam, Alison Brod Marketing Communications, [email protected]