Neck Muscle Issue
Conditions
Keywords
Neck circumference, Neck aesthetics, Sternocleidomastoid muscles (SCM), Botulinum injection, PrabotulinumtoxinA-xvfs injection
Brief summary
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.
Detailed description
The specific study objectives are to determine if: * 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.
Interventions
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.
Sponsors
Evolus, Inc.
Boston Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age eligible individual seeking a more feminine neck appearance
Exclusion criteria
* Prior neuromodulator injections in the sternocleidomastoid muscles (SCM) within the past year * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck circumference | Baseline, 4 weeks | A standard tape measure will be used and circumference recorded in centimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post injection neck appearance | 4 weeks | 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. |
Countries
United States
Contacts
Primary ContactJeffrey Spiegel, MD
Backup ContactAmanda Goslawski, MD
Outcome results
None listed