BoTox Into the Sternocleidomastoid Muscles (SCM)

NCT06903975 — Phase 4, Recruiting, 30 participants, Boston Medical Center

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The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics

Registry	NCT06903975
Status	Recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Boston Medical Center (Other); collaborators: Evolus, Inc.
Conditions	Neck Muscle Issue
Interventions	prabotulinumtoxinA-xvfs (Drug)
Dates	start 2025-05-14, primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2025-04-01, last updated 2026-08-31
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Botulinum injection into SCM	Experimental	Drug: prabotulinumtoxinA-xvfs	All participants will receive bilateral botulinum injections into the SCM.

prabotulinumtoxinA-xvfs (Drug), also known as Jeuveau: 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.

+Outcome measures

Primary outcomes

Neck circumference [Baseline, 4 weeks]: A standard tape measure will be used and circumference recorded in centimeters

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
The Spiegel Center	Newton, Massachusetts	United States	Recruiting

+Investigators

Jeffrey Spiegel, MD, Principal investigator, Boston Medical Center and The Spiegel Center