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Study of NT 201 compared to placebo in adults with moderate to severe platysma prominence

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Platysma Prominence, a condition where neck bands become visibly prominent. The research evaluates a medication called NT 201 (also known as Bocouture), which contains Botulinum toxin type A, compared to placebo for treating moderate to severe cases of this condition. The platysma is a thin, flat muscle in the neck that can become more noticeable with age, causing visible vertical bands.

The purpose of this research is to determine how safe and effective NT 201 is when used as a treatment for people with moderate to severe platysma bands in the neck area. The study involves giving participants either the active medication or placebo through intramuscular injections. Some participants will receive the actual treatment while others will receive a placebo solution that looks identical to the real medication.

During the study, participants will receive treatments and have their neck appearance evaluated multiple times. The medication will be administered as an infusion solution directly into the platysma muscle. The maximum amount of medication that can be given in a single day is 96 units, with a total possible amount of 192 units over the entire treatment period, which lasts approximately 17 weeks.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    You will receive a single treatment of either NT 201 or placebo through intramuscular injection.

    The placebo consists of sucrose and human serum albumin mixed with sterile saline.

    The active medication contains botulinum neurotoxin type A without complexing proteins.

    The treatment will be administered into your platysma muscles (neck muscles).

  2. Step 2

    2-week assessment

    After 2 weeks (Visit 4), your progress will be evaluated based on:

    The doctor will assess the appearance of your neck muscles using a grading scale.

    You will complete a self-assessment of your neck muscle appearance.

    You will fill out a satisfaction questionnaire about the treatment results.

  3. Step 3

    Follow-up period

    The study continues with regular follow-up visits to monitor your progress.

    The doctor will assess if you achieve either 'none to minimal' or 'mild' muscle prominence.

    Your improvement will be measured as a change of at least 2 grades from your starting condition.

  4. Step 4

    Repeat treatment

    You may receive additional treatment during the study period.

    The study is expected to continue until October 11, 2027.

    Regular assessments will continue throughout the study period to monitor safety and effectiveness.

Who can join the trial?

8 criteria

  • Must be between 18 and 65 years old when agreeing to participate in the study
  • Must have four visible neck bands (two on each side of the neck - inner and outer platysma bands)
  • Must have either moderate or severe prominence of neck bands when contracting neck muscles, as evaluated by both the doctor and participant (evaluations may differ)
  • Must be bothered by the appearance of their neck and score at least 16 points on a special questionnaire about neck appearance concerns
  • For women participants:
    • Must not be pregnant or breastfeeding
    • Must either be unable to have children (for example, due to menopause), OR
    • If able to have children, must use approved birth control methods during the study
    • Both men and women can participate in the study if they meet all other requirements

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with botulinum toxin (a protein that temporarily relaxes muscles) in the neck area within the past 4 months
  • Known allergy or sensitivity to the study medication or its components
  • Pregnancy or breastfeeding
  • Active infection or inflammation in the treatment area
  • History of difficulty swallowing (dysphagia)
  • Neuromuscular junction disorders (conditions affecting nerve and muscle connections) such as myasthenia gravis
  • Use of medications that could interfere with neuromuscular function
  • Previous neck surgery or significant scarring in the treatment area
  • Any medical condition that could affect the safety of the participant or the study results
  • Current participation in other clinical trials or within 30 days before study start
  • Inability to follow study procedures or attend follow-up visits
  • History of drug or alcohol abuse within the past year
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Investigated drugs

NT 201 is a medication being studied for treating moderate to severe platysma prominence (visible neck bands). It is a type of injectable treatment that targets the muscles in the neck area. The medication works by temporarily reducing muscle activity in the platysma, which are the muscles that cause visible bands in the neck. Placebo is an inactive substance used as a comparison to measure the true effects of NT 201. It looks identical to the active treatment but contains no active ingredients. Note: Both treatments are given as injections into the neck area where the muscle bands are visible.

What is already known about the treatment

NT 201 – A therapeutic agent currently undergoing Phase 3 clinical trials for the treatment of moderate to severe platysma prominence (visible neck bands). This injectable medication belongs to the class of neuromuscular blocking agents and is being studied for its potential cosmetic and therapeutic applications in neck aesthetics. The substance works by temporarily inhibiting muscle contractions in the platysma muscle, which may help reduce the appearance of prominent neck bands. The medication is being evaluated in a double-blind, multicenter study to assess both its safety profile and effectiveness compared to placebo in adult patients.

Investigated diseases

Platysma Prominence - A cosmetic condition where the platysma muscles in the neck become more visible and pronounced, creating visible bands or cords. The platysma is a broad, thin sheet of muscle that extends from the chest and shoulder regions up to the jaw. When these muscles become more prominent with age or genetic predisposition, they can create visible vertical bands in the neck area, particularly noticeable during facial expressions or muscle tension. The condition can range from mild to severe, with more severe cases showing very distinct rope-like bands in the neck. This condition often becomes more noticeable as people age due to loss of skin elasticity and subcutaneous fat in the neck area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520499-24-00Protocol codeNT-PPR-EU002Estimated enrolment300 patientsSponsorMerz Aesthetics GmbH

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