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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

73 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

Study team and timeline

Lead sponsor

Merz Aesthetics GmbH

Study start

Mar 22, 2023 Actual

Primary completion

Oct 19, 2023 Actual

Study completion

Jan 24, 2024 Actual

First posted

Mar 17, 2023 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.