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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Botox injections into the sternocleidomastoid muscle (a muscle on the side of the neck) can temporarily slim the neck and create a more feminine and youthful appearance. Botox has been used for years on the face and neck, but this study specifically examines its effects on neck appearance. Participants will receive Botox injections in their neck muscles to evaluate these cosmetic benefits. Suitable candidates are those seeking a more feminine neck appearance and who have not undergone similar neck treatments in the past year. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, with the goal of understanding how it benefits more patients.

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 is the safety track record for prabotulinumtoxinA-xvfs?

Research has shown that prabotulinumtoxinA-xvfs, like other botulinum toxin treatments, is generally safe for cosmetic use. Studies have found that using botulinum toxin for neck bands is as safe as for other cosmetic purposes, with side effects typically mild and temporary. The FDA has approved similar products for use in the neck area, indicating a strong safety record. Overall, most patients tolerate this treatment well, with few side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for improving neck appearance involve surgical procedures or topical creams. However, prabotulinumtoxinA-xvfs offers a unique approach by using botulinum injections directly into the sternocleidomastoid (SCM) muscles. This method allows for targeted relaxation of specific muscles, potentially leading to a more defined neck profile. Researchers are excited about this treatment because it promises non-surgical results with minimal downtime, providing a quicker and less invasive option compared to traditional methods.

What evidence suggests that this treatment might be an effective treatment for neck appearance?

Research has shown that botulinum toxin injections, such as prabotulinumtoxinA-xvfs, can enhance the appearance of the neck by targeting muscles like the platysma. Studies have found that these injections increase participant satisfaction, with noticeable improvements such as reduced visibility of neck bands. In one study, 92.5% of patients experienced a significant reduction in neck bands within four weeks, with effects lasting up to 12 weeks. Although typically used for neck spasms, these findings suggest the injections might also improve neck shape, providing a more youthful appearance. This treatment has been well-tolerated in similar applications, showing promise for enhancing neck aesthetics. ^{2 5 6 7 8}

Who Is on the Research Team?

Jeffrey Spiegel, MD

Principal Investigator

Boston Medical Center and The Spiegel Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38640068/

A Randomized Phase 2 Dose-Ranging Study OnabotulinumtoxinA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated.

2. jaad.org jaad.org/article/S0190-9622(24)03035-4/fulltext

Improvement of platysma prominence with ... OnabotulinumtoxinA-treated participants reported higher satisfaction, less bother from jawline and vertical neck band appearance, and reduced ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.70301

Optimizing Botulinum Toxin Injections in the Platysma ... Targeted injections produced a ≥ 2-grade reduction in dynamic bands in 92.5% of patients by week 4, maintained through week 12. Mean toxin use ...

4. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2025/01000/efficacy_and_safety_of_onabotulinumtoxina_for_the.18.aspx

Efficacy and Safety of OnabotulinumtoxinA for the ... OnabotulinumtoxinA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated.

5. beerdermatology.com beerdermatology.com/wp-content/uploads/2025/02/onabotulinumtoxina-for-platysma-prominence-at-maximum-contraction.pdf

OnabotulinumtoxinA for Platysma Prominence at Maximum ... Conclusions: Repeat onabotA treatment is well-tolerated and improves platysma prominence for up to 1 year. Keywords: onabotulinumtoxinA, platysma muscle, lower ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5316s5319s5323s5326s5331lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION The safety profile of BOTOX Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX Cosmetic for other indications.

7. botoxcosmetic.com botoxcosmetic.com/treatment-areas/vertical-bands-connecting-the-neck-and-jaw

Vertical Bands Connecting the Neck and Jaw The first and only product FDA approved to temporarily make moderate to severe vertical bands connecting the neck and jaw (platysma bands) look better in adults ...

8. news.abbvie.com news.abbvie.com/2024-10-18-BOTOX-R-Cosmetic-onabotulinumtoxinA-Receives-FDA-Approval-for-Moderate-to-Severe-Vertical-Bands-Connecting-the-Jaw-and-Neck-Platysma-Bands

BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA ... BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) - ...