BoTox Into the Sternocleidomastoid Muscles (SCM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prabotulinumtoxinA-xvfs.
- Who it may be relevant to
- Registry conditions: Neck Muscle Issue. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics
Overview
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.
Interventions
- Drug prabotulinumtoxinA-xvfs
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.
Primary outcome measures
- Neck circumference [Time frame: Baseline, 4 weeks]
Secondary outcome measures (1)
- Post injection neck appearance [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Spiegel Center — Newton
Identifiers
NCT: NCT06903975 · H-45473