Botox for Neck Appearance

Overseen By Jeffrey Spiegel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Medical Center

Must not be taking: Anticoagulants, Semaglutide

Disqualifiers: BMI >30, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stop taking anticoagulants (medications that prevent blood clotting) if you are currently using them.

What data supports the effectiveness of the drug prabotulinumtoxinA-xvfs for improving neck appearance?

Research on similar treatments, like botulinum toxin type A, shows they are effective in improving neck appearance by reducing wrinkles and signs of aging. Studies have demonstrated positive results and high patient satisfaction with these treatments for neck rejuvenation. ^{1 2 3 4 5}

Is prabotulinumtoxinA-xvfs safe for use in humans?

PrabotulinumtoxinA-xvfs, a type of botulinum toxin A, has been approved by the FDA for cosmetic use, and clinical trials have assessed its safety for improving the appearance of glabellar lines. Generally, botulinum toxin treatments are considered safe, with mild-to-moderate side effects that usually resolve quickly. ^{6 7 8 9 10}

How is the drug prabotulinumtoxinA-xvfs different from other treatments for neck appearance?

PrabotulinumtoxinA-xvfs is a type of botulinum toxin used for neck rejuvenation, similar to other botulinum toxin type A treatments, which are known for their effectiveness in reducing neck wrinkles and improving neck appearance without the need for surgery. It offers a non-invasive option with minimal recovery time, making it appealing for those who want to avoid the risks of surgical procedures. ^{1 2 3 5 7}

What is the purpose of 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.

Research Team

Jeffrey Spiegel, MD

Principal Investigator

Boston Medical Center and The Spiegel Center

Eligibility Criteria

This trial is for individuals seeking a more feminine neck appearance through temporary slimming of the neck. Candidates must not have allergies to botulinum toxin A, be pregnant or breastfeeding, have a BMI over 30, had prior SCM injections in the last year, use anticoagulants, or expect significant weight changes.

Inclusion Criteria

I want my neck to look more feminine.

Exclusion Criteria

Prior allergy to botulinum toxin A

Currently pregnant or breastfeeding

Body mass index (BMI) >30

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bilateral botulinum injections into the sternocleidomastoid muscles

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in neck circumference and aesthetics, and for safety based on adverse events

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• prabotulinumtoxinA-xvfs

Trial Overview The study tests if injecting prabotulinumtoxinA-xvfs (a type of botulinum toxin) into the sternocleidomastoid muscles can create a slimmer and more youthful neck contour. It's previously been used for facial aesthetics and treating spasms but not for this specific cosmetic effect on the neck.

Participant Groups

Group I: Botulinum injection into SCM Experimental Treatment 1 Intervention

All participants will receive bilateral botulinum injections into the SCM.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Evolus, Inc.

Industry Sponsor

Trials

9

Recruited

2,500+

Findings from Research

In a study involving 23 subjects, incobotulinumtoxinA effectively reduced the appearance of platysmal bands, with 100% of participants showing improvement by Day 8 after treatment.

The treatment was well-tolerated with no serious adverse events reported, and subjects reported significant satisfaction with their results, particularly at maximum tension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. Prager, W., Bee, EK., Havermann, I., et al.[2014]

A review of studies involving 112 women aged 24 to 65 indicates that Botulinum toxin type A (BTX-A) is likely effective for treating neck wrinkles, achieving high patient satisfaction rates without serious side effects.

While the evidence for BTX-A's aesthetic effects on neck wrinkles is not definitive, it shows promise as a treatment option, especially when used alone or in combination with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aesthetic Concerns of Botulinum Toxin Type A in the Treatment of Neck Wrinkles: A Systematic Review. Qiu, H., Zhao, R., Cao, L., et al.[2021]

A systematic review of 10 studies involving various cosmetic uses of abobotulinumtoxinA (aboBoNT-A) showed positive outcomes in reducing wrinkles and improving facial aesthetics, with no serious adverse events reported.

Patient satisfaction was high across the studies, indicating that aboBoNT-A is a safe and effective option for cosmetic treatments in the middle and lower face and neck, warranting further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of AbobotulinumtoxinA for Cosmetic Treatments in the Neck, and Middle and Lower Areas of the Face: A Systematic Review. Galadari, H., Galadari, I., Smit, R., et al.[2021]

A study involving 15 patients compared the effects of onabotulinumtoxinA and prabotulinumtoxinA-xvfs on forehead and glabella wrinkles, finding no significant differences in onset of action or patient satisfaction between the two treatments.

Both formulations of botulinum toxin A were equally effective in reducing dynamic wrinkles, although there was a slight trend suggesting that patients may prefer onabotulinumtoxinA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA versus PrabotulinumtoxinA-xvfs: A Randomized, Triple-blind, Split-face Study on the Time to Onset, Rhytid Appearance, and Patient Satisfaction in Forehead and Glabellar Lines. Vasile, G., Green, C., Bhatti, H., et al.[2023]

PrabotulinumtoxinA-xvfs (Jeuveau) significantly improved the appearance of moderate-to-severe glabellar lines, with 67.5% to 70.4% of patients showing a greater than 2-point improvement on the Glabellar Line Scale compared to only 1.2% to 1.3% in placebo groups across two clinical trials.

The treatment was well tolerated, demonstrating safety, and showed greater efficacy than onabotulinumtoxinA, with 87.2% of patients achieving improvement compared to 82.8% for onabotulinumtoxinA and 4.2% for placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines. Gadarowski, MB., Ghamrawi, RI., Taylor, SL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study. [2014]

2. England pubmed.ncbi.nlm.nih.gov

The Aesthetic Concerns of Botulinum Toxin Type A in the Treatment of Neck Wrinkles: A Systematic Review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA from lines to facial reshaping: A new Italian consensus report. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Use of AbobotulinumtoxinA for Cosmetic Treatments in the Neck, and Middle and Lower Areas of the Face: A Systematic Review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin for rejuvenation of the neck. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA versus PrabotulinumtoxinA-xvfs: A Randomized, Triple-blind, Split-face Study on the Time to Onset, Rhytid Appearance, and Patient Satisfaction in Forehead and Glabellar Lines. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Botulinum neurotoxin type B--a rapid wrinkle reducer. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study). [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical equivalence of conventional OnabotulinumtoxinA (900 KDa) and IncobotulinumtoxinA (neurotoxin free from complexing proteins - 150 KDa): 2012 multidisciplinary French consensus in aesthetics. [2018]