NCT05773053CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merz Aesthetics GmbH
- Enrollment
- 73
- Locations
- 7
- Primary Endpoint
- Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 & Interventions
NT 201 Dose 1
Experimental
Subjects will receive Dose 1.
Intervention: NT 201 (Drug)
NT 201 Dose 2
Experimental
Subjects will receive Dose 2.
Intervention: NT 201 (Drug)
NT 201 Dose 3
Experimental
Subjects will receive Dose 3.
Intervention: NT 201 (Drug)
Placebo
Placebo Comparator
Subjects will receive matching placebo.
Intervention: NT 201 Placebo (Drug)
Outcomes
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
- Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)(Baseline up to Week 17/End of Study)
- Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4(Baseline (Screening Visit), Week 2 (V4))
Investigators
Study Sites (7)
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