Clinical trial NCT05773053: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Platysma Prominence
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)
timeFrame: Baseline (Screening Visit), Week 2 (V4)
Secondary outcomes:
measure: Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4
timeFrame: Baseline (Screening Visit), Week 2 (V4)
measure: Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)
timeFrame: Baseline up to Week 17/End of Study
Other outcomes:
Locations:
city: Washington
country: United States
facility: Merz Investigation Site #0010170
state: District of Columbia
city: Aventura
country: United States
facility: Merz Investigational Site #0010453
state: Florida
city: Coral Gables
country: United States
facility: Merz Investigation Site #0010470
state: Florida
city: Metairie
country: United States
facility: Merz Investigation Site #0010105
state: Louisiana
city: Verona
country: United States
facility: Merz Investigation Site #0010471
state: New Jersey
city: New York
country: United States
facility: Merz Investigation Site #0010469
state: New York
city: New York
country: United States
facility: Merz Investigation Site #0010405
state: New York
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: