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This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety, immunogenicity and efficacy of JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Single injection with JHM03 in glabellar lines |
|
| Active-Controlled Group | Active Comparator | Single injection with BOTOX® in glabellar lines |
|
| Placebo-Controlled Group | Placebo Comparator | Single injection with Placebo in glabellar lines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JHM03 | Biological | Single treatment, intramuscularly injected into five sites. The total injection volume is 0.5 ml,0.1 ml per site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase1 | The incidence rate of adverse events and severe adverse events within 28 days after injection; | Within 28 days |
| Phase2 | Percentage of Subjects as Responders in the Investigator's live assessment (Using 4-point Photographic Scale) and the subject's self assessment of Glabellar Lines at Maximum Frown. | within 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | China |
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Placebo and active controlled
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Double-blinded
| BOTOX® | Biological | Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site. |
|
| Placebo | Biological | Single treatment,intramuscularly injected into five sites.The total injection volume is 0.5 ml,0.1 ml per site. |
|
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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