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RECRUITING
NCT06481475
PHASE2

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

Sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

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.

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