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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose YY003 | Experimental | Participants will receive a single dose over 5 injection sites on Day 1. |
|
| High dose YY003 | Experimental | Participants will receive a single dose over 5 injection sites on Day 1. |
|
| Vehicle control | Placebo Comparator | Participants will receive a single dose over 5 injection sites on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YY003 | Biological | Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs) | 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 | at Week 4 post-treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-drug antibodies and neutralizing antibodies | Within 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Dermatology & Skin Cancer Centre | Sydney | New South Wales | 2217 | Australia | ||
| Skin Health Institute |
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| Vehicle Control | Biological | Single treatment, intramuscularly injected into five sites. The total injection volume is 0.25 ml, 0.05 ml per site. |
|
| Melbourne |
| Victoria |
| 3053 |
| Australia |
| Dermatology Institute of Victoria | Melbourne | Victoria | 3141 | Australia |