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A Study to Investigate the Safety and Efficacy of YY003 in Adults with Moderate to Severe Glabellar Lines
Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2025-01-09
Completion Date
2025-10
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
YY003
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Vehicle Control
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Locations (3)
St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, Australia
Skin Health Institute
Melbourne, Victoria, Australia
Dermatology Institute of Victoria
Melbourne, Victoria, Australia