A Phase 3, randomized, parallel-group, double-blind, multicenter study investigating the safety and efficacy of NT 201 compared with placebo in adult participants with moderate to severe platysma prominence in Europe

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merz Aesthetics GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

1 Oct 2025 → ongoing

Decision date (initial)

2026-02-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merz Aesthetics GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety and efficacy of a single and repeat treatment of NT 201 in participants with moderate to severe platysma prominence compared with placebo

Conditions and MedDRA coding

Moderate to Severe Platysma Prominence

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Is male or female between ≥ 18 and ≤ 65 years old at the time of signing the informed consent.
2. 2. Presence of four (medial and lateral, left and right) platysmal bands.
3. 3. Has a score of Grade 3 (‘moderate’) or Grade 4 (‘severe’) on the MAPS-D at maximum contraction, as assessed by the investigator and participant (the ratings of the investigator and participant do not have to coincide).
4. 4. Has a response of ‘agree’ or ‘strongly agree’ to Platysma PRO Item #1 (“I am bothered by the appearance of my neck”) AND attain a total score of ≥ 16 for platysma PRO.
5. 5. For female participants only: A participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: • Is of non-childbearing potential as defined in the protocol. OR • Is of childbearing potential (CBP) and using an acceptable contraceptive method as described in the protocol.

Exclusion criteria 7

1. 1. Known hypersensitivity or history of allergic reaction to BoNT of any serotype or any of their formulation ingredients.
2. 2. Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorders that might interfere with neuromuscular function.
3. 3. Any serious disease or disorder that could, in the judgment of the investigator, interfere with the safe completion of treatment according to this protocol or with study outcome assessments, or compromise participant safety.
4. 4. BoNT treatment in the face, jawline, or neck within the last seven months prior to study treatment.
5. 5. History of lower face surgery, neck or chest surgery, aesthetic procedures, and orthodontic procedures in the 12 months prior to study treatment, or any other procedures which in the investigator’s judgment would interfere with study evaluations.
6. 6. Previous use of any permanent or semi-permanent, calcium hydroxylapatite, facial tissue augmentation therapy, lifting sutures, permanent implants, or autologous fat to the lower face, neck, or chest within 12 months prior to study treatment.
7. 7. Previous use of any hyaluronic acid-based or collagen-based biodegradable facial tissue augmentation therapy to the lower face, neck, or chest within 12 months prior to study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least a 2-grade improvement from baseline based on both the investigator’s assessment and participant’s self-assessment using the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).

Secondary endpoints 3

1. • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least 2-grade improvement from baseline based on the investigator’s assessment using MAPS-D at V4.
2. • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least a 2-grade improvement from baseline based on the participant’s self-assessment using MAPS-D at V4.
3. • Achievement of at least a +1 (‘somewhat satisfied’) score using the participant’s satisfaction questionnaire at V4.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merz Aesthetics GmbH

Sponsor organisation

Merz Aesthetics GmbH

Address

Eckenheimer Landstrasse 100, Nordend-West Nordend-West

City

Frankfurt Am Main

Postcode

60318

Country

Germany

Scientific contact point

Organisation

Merz Aesthetics GmbH

Contact name

Public Disclosure Manager, Merz Aesthetics

Public contact point

Organisation

Merz Aesthetics GmbH

Contact name

Public Disclosure Manager, Merz Aesthetics

Third parties 9

Locations

4 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 83 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications