BoTox Into the Sternocleidomastoid Muscles (SCM)

NCT06903975 | Recruiting Phase 4 FDA Drug

• 1 other identifier: H-45473
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Muscle Issue

Keywords

Neck circumference; Neck aesthetics; Sternocleidomastoid muscles (SCM); Botulinum injection; PrabotulinumtoxinA-xvfs injection

Outcome Measures

Primary Outcomes (1)

• Neck circumference

  A standard tape measure will be used and circumference recorded in centimeters

  Baseline, 4 weeks

Secondary Outcomes (1)

• Post injection neck appearance

  4 weeks

Study Arms (1)

Botulinum injection into SCM

EXPERIMENTAL

All participants will receive bilateral botulinum injections into the SCM.

Drug: prabotulinumtoxinA-xvfs

Interventions

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.

Also known as: Jeuveau

Botulinum injection into SCM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age eligible individual seeking a more feminine neck appearance

You may not qualify if:

• 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

Sponsors & Collaborators

• Evolus, Inc.: collaborator
• Boston Medical Center: lead

Study Sites (1)

The Spiegel Center

Newton, Massachusetts, 02459, United States

RECRUITING

MeSH Terms

Interventions

prabotulinumtoxin A

Study Officials

• Jeffrey Spiegel, MD

  Boston Medical Center and The Spiegel Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Spiegel, MD

CONTACT

617 566-3223; Jeffrey.Spiegel@bmc.org

Amanda Goslawski, MD

CONTACT

617 638-7934; Amanda.Goslawski@bmc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 1, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)