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

Platysma Prominence Clinical Trial

— PAOLA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773053
• Other study ID #: M602011078
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2023
• Est. completion date: January 24, 2024

Study information

• Verified date: January 2024
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 24, 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Platysma Prominence

Intervention

Drug:
• NT 201
Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.
• NT 201 Placebo
NT 201 Matching-placebo.

Locations

Country	Name	City	State
United States	Merz Investigational Site #0010453	Aventura	Florida
United States	Merz Investigation Site #0010470	Coral Gables	Florida
United States	Merz Investigation Site #0010105	Metairie	Louisiana
United States	Merz Investigation Site #0010405	New York	New York
United States	Merz Investigation Site #0010469	New York	New York
United States	Merz Investigation Site #0010471	Verona	New Jersey
United States	Merz Investigation Site #0010170	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merz Aesthetics GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (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).	Baseline (Screening Visit), Week 2 (V4)
Secondary	Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4	The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).	Baseline (Screening Visit), Week 2 (V4)
Secondary	Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)	TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible.	Baseline up to Week 17/End of Study