---
title: A Study of NT 201 Doses in the Treatment of Platysma Prominence
nct_id: NCT05773053
overall_status: COMPLETED
phase: PHASE2
sponsor: Merz Aesthetics GmbH
study_type: INTERVENTIONAL
primary_condition: Platysma Prominence
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05773053.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05773053"
ct_last_update_post_date: 2024-10-21
last_seen_at: "2026-05-12T07:11:55.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of NT 201 Doses in the Treatment of Platysma Prominence

**Official Title:** A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence

**NCT ID:** [NCT05773053](https://clinicaltrials.gov/study/NCT05773053)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 73
- **Lead Sponsor:** Merz Aesthetics GmbH
- **Conditions:** Platysma Prominence
- **Start Date:** 2023-03-22
- **Completion Date:** 2024-01-24
- **CT.gov Last Update:** 2024-10-21

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Presence of four (medial and lateral, left and right) prominent platysmal bands
* Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction

Exclusion Criteria:

* Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
* Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
* History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
* Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
* Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating
```

## Arms

- **NT 201 Dose 1** (EXPERIMENTAL) — Subjects will receive Dose 1.
- **NT 201 Dose 2** (EXPERIMENTAL) — Subjects will receive Dose 2.
- **NT 201 Dose 3** (EXPERIMENTAL) — Subjects will receive Dose 3.
- **Placebo** (PLACEBO_COMPARATOR) — Subjects will receive matching placebo.

## Interventions

- **NT 201** (DRUG) — Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.
- **NT 201 Placebo** (DRUG) — NT 201 Matching-placebo.

## Primary Outcomes

- **Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)** _(time frame: Baseline (Screening Visit), Week 2 (V4))_ — The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).

## Secondary Outcomes

- **Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4** _(time frame: Baseline (Screening Visit), Week 2 (V4))_
- **Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)** _(time frame: Baseline up to Week 17/End of Study)_

## Locations (7)

- Merz Investigation Site #0010170, Washington D.C., District of Columbia, United States
- Merz Investigational Site #0010453, Aventura, Florida, United States
- Merz Investigation Site #0010470, Coral Gables, Florida, United States
- Merz Investigation Site #0010105, Metairie, Louisiana, United States
- Merz Investigation Site #0010471, Verona, New Jersey, United States
- Merz Investigation Site #0010469, New York, New York, United States
- Merz Investigation Site #0010405, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.merz investigation site #0010170|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.merz investigational site #0010453|aventura|florida|united states` — added _(2026-05-12)_
- `locations.merz investigation site #0010470|coral gables|florida|united states` — added _(2026-05-12)_
- `locations.merz investigation site #0010105|metairie|louisiana|united states` — added _(2026-05-12)_
- `locations.merz investigation site #0010471|verona|new jersey|united states` — added _(2026-05-12)_
- `locations.merz investigation site #0010469|new york|new york|united states` — added _(2026-05-12)_
- `locations.merz investigation site #0010405|new york|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05773053.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05773053*  
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