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| Name | Class |
|---|---|
| Evolus, Inc. | INDUSTRY |
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Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour.
The specific study objectives are to determine if:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum injection into SCM | Experimental | All participants will receive bilateral botulinum injections into the SCM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prabotulinumtoxinA-xvfs | Drug | Each participant will receive 60 units (U) of prabotulinumtoxinA-xvfs into each SCM for a total of 120 U. Participants will return in 2 weeks to determine if any touch-up injection is needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Neck circumference | A standard tape measure will be used and circumference recorded in centimeters | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post injection neck appearance | A 5-item investigator developed questionnaire will be used to assess each participant's opinion about their neck appearance after the botulinum toxin injections. Each item has 4 potential responses from 1=Definitely disagree to 4=Definitely agree. Total scores can range from 5 to 20 and higher scores suggest more positive opinions about their neck appearance. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Spiegel, MD | Contact | 617 566-3223 | Jeffrey.Spiegel@bmc.org | |
| Amanda Goslawski, MD | Contact | 617 638-7934 | Amanda.Goslawski@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Spiegel, MD | Boston Medical Center and The Spiegel Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Spiegel Center | Recruiting | Newton | Massachusetts | 02459 | United States |
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| ID | Term |
|---|---|
| C000630868 | prabotulinumtoxin A |
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