Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-05-14
2026-03-31
Brief Summary
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Detailed Description
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* the neck circumference is decreased at 4 weeks after botulinum toxin (prabotulinumtoxinA-xvfs) injection.
* patients can appreciate a difference in their neck contour, self-confidence, and the way they perceive themselves post-injection via an aesthetics outcome and a neck perception survey.
* injection of the botulinum toxin into the sternocleidomastoid muscle is safe to perform based on adverse events.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Botulinum injection into SCM
All participants will receive bilateral botulinum injections into the SCM.
prabotulinumtoxinA-xvfs
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.
Interventions
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prabotulinumtoxinA-xvfs
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Current anticoagulant use
* Body mass index (BMI) \>30
* Anticipation of significant weight gain or loss during the study period (e.g. patients taking or planning to take within the study period a semaglutide medication.)
* Prior allergy to botulinum toxin A
* Currently pregnant or breastfeeding
18 Years
65 Years
ALL
Yes
Sponsors
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Evolus, Inc.
INDUSTRY
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Spiegel, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center and The Spiegel Center
Locations
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The Spiegel Center
Newton, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-45473
Identifier Type: -
Identifier Source: org_study_id
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