NCT06499688

A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

A Randomized, Double-blind, Placebo- and Active-controlled Parallel-group Multi-center Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 529 (actual)
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin type A for injection (YY001)) in the treatment of moderate to severe glabellar lines.

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	Rcombinant botulinum neurotoxin type A for injection (YY001)	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
BIOLOGICAL	OnabotulinumtoxinA	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
BIOLOGICAL	Placebo	Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.

Timeline

• Start date: 2023-12-28
• Primary completion: 2024-03-29
• Completion: 2024-05-31
• First posted: 2024-07-12
• Last updated: 2024-07-24

Locations

16 sites across 1 country: China