Neck Muscle IssuePhase 4NCT06903975
BoTox Into the Sternocleidomastoid Muscles (SCM)
A Phase 4 study testing prabotulinumtoxinA-xvfs in people with Neck Muscle Issue, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Muscle Issue
- What is being tested?
- prabotulinumtoxinA-xvfs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age eligible individual seeking a more feminine neck appearance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Spiegel Center
Newton, Massachusetts, 02459
Jeffrey Spiegel, MD, drspiegel@drspiegel.com
Amanda Goslawski, MD, Amanda.Goslawski@bmc.org
About this study
Official title: The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics
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.
Read the 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.
- Conditions
- Neck Muscle Issue
- Being tested
- prabotulinumtoxinA-xvfs
- Keywords
- Neck circumference, Neck aesthetics, Sternocleidomastoid muscles (SCM), Botulinum injection, PrabotulinumtoxinA-xvfs injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prabotulinumtoxinA-xvfsDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum injection into SCM | Experimental | All participants will receive bilateral botulinum injections into the SCM. Receives: Drug: prabotulinumtoxinA-xvfs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck circumference
A standard tape measure will be used and circumference recorded in centimeters
Measured: Baseline, 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start14 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck Muscle IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Evolus, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Spiegel, MD, Principal investigator, Boston Medical Center and The Spiegel Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903975
- Sponsor's protocol ID
- H-45473
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics
- ClinicalTrials.gov ID
- NCT06903975
- Acronym / sponsor ID
- H-45473
- Conditions
- Neck Muscle Issue
- Keywords
- Neck circumference, Neck aesthetics, Sternocleidomastoid muscles (SCM), Botulinum injection, PrabotulinumtoxinA-xvfs injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Evolus, Inc.
- Study start
- 14 May 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum injection into SCM | Experimental | Drug: prabotulinumtoxinA-xvfsAll participants will receive bilateral botulinum injections into the SCM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age eligible individual seeking a more feminine neck appearance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prabotulinumtoxinA-xvfsAlso: JeuveauEach 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. | Drug | Botulinum injection into SCM |
Primary outcome
Neck circumference
Time frame: Baseline, 4 weeks
A standard tape measure will be used and circumference recorded in centimeters
1 secondary outcome
Post injection neck appearance
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Spiegel, MD principal investigator
Boston Medical Center and The Spiegel Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prabotulinumtoxinA-xvfs in people with Neck Muscle Issue, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Spiegel, MD (617 566-3223, Jeffrey.Spiegel@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck circumference (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.