BoTox Into the Sternocleidomastoid Muscles (SCM)

Phase 4

Recruiting

• Conditions: Neck Muscle Issue
• Interventions: Drug: prabotulinumtoxinA-xvfs

• Registration Number: NCT06903975
• Lead Sponsor: Boston Medical Center

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.

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Study First Posted: 2025-04-01
• Study Start: 2025-05-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum injection into SCM	prabotulinumtoxinA-xvfs	All participants will receive bilateral botulinum injections into the SCM.

Primary Outcome Measures

Name	Time	Method
Neck circumference	Baseline, 4 weeks	A standard tape measure will be used and circumference recorded in centimeters

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Spiegel Center; 🇺🇸 Newton, Massachusetts, United States