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To assess the safety and injection comfort of ATX-101-BA versus ATX-101-BA-free immediately following injection and at regular intervals up to 24-hours post-injection following subcutaneous administration into the submental area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | Left side injected first: Left submental - ATX-101-BA Right submental - ATX-101-BA-free |
|
| Group 1B | Experimental | Right side injected first: Left submental - ATX-101-BA Right submental - ATX-101-BA-free |
|
| Group 2A | Experimental | Left side injected first: Left submental - ATX-101-BA-free Right submental - ATX-101-BA |
|
| Group 2B | Experimental | Right side injected first: Left submental - ATX-101-BA-free Right submental - ATX-101-BA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-101-BA-free | Drug | ATX-101-BA-free |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort measure | The primary measure of comfort is the pain comparison scale between ATX-101-BA and ATX-101-BA-free at the time of injection using the pain comparison scale and the VAS pain rating scale. | up to 24 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Walker, M.D. | Kythera Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joel Schlessinger, M.D. | Omaha | Nebraska | 68144 | United States | ||
| Jeffrey M. Adelglass, M.D. |
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| ATX-101-BA | Drug | ATX-101-BA |
|
| Plano |
| Texas |
| 75093 |
| United States |