Botox for Neck Muscle Prominence

(PLATINUM US Trial)

Recruiting at 26 trial locations

Overseen By Public Disclosure Manager Merz Aesthetics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merz North America, Inc.

Must not be taking: Botulinum toxin

Disqualifiers: Allergy to botulinum, Neuromuscular disorders, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of NT 201 (a form of botulinum toxin, commonly known as Botox) for individuals with noticeable neck muscles, specifically those with moderate to severe platysma prominence. The trial consists of two parts: the Main Period, where some participants receive NT 201 and others a placebo (a harmless substance with no treatment effect), and an Open Label Extension Period, where all participants receive NT 201. Suitable candidates have visible neck muscle bands and have not recently undergone Botox or surgery on their neck or face. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have had botulinum toxin treatments in the face, jawline, or neck within the last seven months, you may not be eligible to participate.

Is there any evidence suggesting that NT 201 is likely to be safe for humans?

Research has shown that NT 201 is generally well-tolerated by people with noticeable neck muscles. In previous studies, patients reported improvements in the appearance of their necks after receiving NT 201. The treatment proved safe, with only a few mild and temporary side effects.

Another study found that using NT 201 repeatedly over a year remained safe, indicating that the treatment does not become less safe with continued use. While some side effects can occur, they are typically not serious.

These findings suggest that NT 201 could be a safe option for treating prominent neck muscles, though individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike other treatments for neck muscle prominence that generally focus on surgical intervention or less targeted muscle relaxants, NT 201 offers a novel approach. NT 201 is a form of botulinum toxin type A, which is already known for its precision in targeting overactive muscles. This treatment is particularly exciting because it is administered via intramuscular injection, allowing for localized muscle relaxation with potentially fewer side effects. Researchers are hopeful that NT 201’s targeted mechanism of action could provide more effective and longer-lasting results compared to traditional options.

What evidence suggests that NT 201 might be an effective treatment for platysma prominence?

Research has shown that NT 201, a type of botulinum toxin, effectively treats noticeable neck muscles, particularly when the platysma muscle is prominent. Studies have found that this treatment is generally well-tolerated and can enhance the appearance of the neck and jawline. One study discovered that repeated treatments with botulinum toxin improved the look of neck muscles for up to a year. This trial will evaluate NT 201 to determine if it can reduce the visibility of neck muscles, resulting in smoother skin and more defined features. Participants may receive this treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Merz Medical Expert

Principal Investigator

Merz North America, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe platysma prominence, which means visible neck bands. Participants must have a specific grade of neck banding and not have had certain treatments or surgeries near the face, jawline, or neck in recent times. They should not have conditions that could risk their safety with botulinum toxin exposure.

Inclusion Criteria

My muscle pain is rated as moderate or severe at its worst.

Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline

Exclusion Criteria

Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients

I don't have any serious health issues that could affect my safety or the study results.

I haven't had botulinum toxin injections in my face, jawline, or neck in the last 7 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Period (MP)

Participants receive NT 201 or placebo via IM injection on Day 1

17 weeks

1 visit (in-person) on Day 1, assessments at Week 1, 2, 4, and up to Week 17

Open-label Extension Period (OLEX)

Participants receive reinjection of NT 201 on Day 1 of OLEX Cycle 1 and Cycle 2

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NT 201

Trial Overview

The study tests NT 201's safety and effectiveness against a placebo in reducing the appearance of neck bands. It has two phases: an initial Main Period where participants don't know if they're getting NT 201 or placebo, followed by an Open Label Extension where everyone receives NT 201.

How Is the Trial Designed?

Group I: OLEX Period: NT 201 Experimental Treatment 1 Intervention

Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX Cycle 1 and Cycle 2.

Group II: Main Period: NT 201 Experimental Treatment 1 Intervention

Participants will receive NT 201 IM injection, once on Day 1 of the MP.

Group III: Main Period: NT 201 Matching Placebo Placebo Group 1 Intervention

Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.

Who Is Running the Clinical Trial?

Merz North America, Inc.

Lead Sponsor

Trials

67

Recruited

10,000+

Leonard Paolillo

Merz North America, Inc.

Chief Executive Officer

Bachelor of Science in Business Administration from Manhattan College

Dr. McKinnon

Merz North America, Inc.

Chief Medical Officer since 2024

Ph.D. in Pharmacology and Toxicology from the University of Western Ontario

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05773053

A Study of NT 201 Doses in the Treatment of Platysma ...

See Delay Results Type in the Results Data Element definitions for more information. ... The purpose of this study is to assess the safety and efficacy of NT 201 ...

2.

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 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39475141/

Improving Neck and Jawline Aesthetics With ...

OnabotulinumtoxinA was well tolerated and effective at improving moderate to severe PP, including neck bands and jawline definition.

4.

withpower.com

withpower.com/trial/phase-3-neuromuscular-agents-7-2025-0d90c

Botox for Neck Muscle Prominence (PLATINUM US Trial)

The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence.

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT07122193/a-study-of-nt-201-in-adults-with-moderate-to-severe-platysma-prominence-in-the-united-states

A Study of NT 201 in Adults With Moderate to Severe ...

The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe ...

6.

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.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04994535

NCT04994535 | A Study To Assess the Safety and Effects ...

A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence · Study Overview.