NCT06481475

A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines

A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type a Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	YY003	Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
BIOLOGICAL	Vehicle Control	Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2024-07-01
• Last updated: 2025-03-21

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study