BoTox Into the Sternocleidomastoid Muscles (SCM)

ConditionNeck Muscle Issue

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorBoston Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age eligible individual seeking a more feminine neck appearance

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Botulinum injection into SCMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Neck circumference

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

Time frame

Baseline, 4 weeks

Secondary outcomes

Post injection neck appearance

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.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

Evolus, Inc.

Collaborator

Source ClinicalTrials.gov

Apply now