NCT07210463 A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
| NCT ID | NCT07210463 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merz Aesthetics GmbH |
| Condition | Neuromuscular Agents |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-10-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).
Eligibility Criteria
Inclusion Criteria: * Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline. * A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPSD at maximum contraction by the investigator AND participant. Exclusion Criteria: * Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients. * Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function. * Any serious disease or disorder that could interfere with the safe completion of treatment or with study outcome assessments, or compromise participant safety. * Botulinum toxin treatment in the face (below the lower orbital rim), jawline, or neck within the last seven months. * History of lower face surgery, neck or chest surgery, and aesthetic procedures in the past 12 months and/or orthodontic procedures in the past 6 months. * Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period. * Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products).
Contact & Investigator
Merz Medical Expert
STUDY DIRECTOR
Merz Aesthetics GmbH
Frequently Asked Questions
Who can join the NCT07210463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Neuromuscular Agents. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07210463 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07210463 currently recruiting?
Yes, NCT07210463 is actively recruiting participants. Contact the research team at Aesthetic.Trials@merz.com for enrollment information.
Where is the NCT07210463 trial being conducted?
This trial is being conducted at Lyon, France, Munich, Germany, Blankenfelde-Mahlow, Germany, Potsdam, Germany and 11 additional locations.
Who is sponsoring the NCT07210463 clinical trial?
NCT07210463 is sponsored by Merz Aesthetics GmbH. The principal investigator is Merz Medical Expert at Merz Aesthetics GmbH. The trial plans to enroll 300 participants.