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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site.
St George Dermatology & Skin Cancer Centre
Sydney, New South Wales, Australia
Skin Health Institute
Melbourne, Victoria, Australia
Dermatology Institute of Victoria
Melbourne, Victoria, Australia
Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)
Time frame: within 4 weeks post-treatment
Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown
Time frame: at Week 4 post-treatment visit
Incidence of anti-drug antibodies and neutralizing antibodies
Time frame: Within 12 Weeks
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