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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-01-24

Brief Summary

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

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Detailed Description

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Conditions

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Platysma Prominence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NT 201 Dose 1

Subjects will receive Dose 1.

Group Type EXPERIMENTAL

NT 201

Intervention Type DRUG

Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.

NT 201 Dose 2

Subjects will receive Dose 2.

Group Type EXPERIMENTAL

NT 201

Intervention Type DRUG

Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.

NT 201 Dose 3

Subjects will receive Dose 3.

Group Type EXPERIMENTAL

NT 201

Intervention Type DRUG

Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.

Placebo

Subjects will receive matching placebo.

Group Type PLACEBO_COMPARATOR

NT 201 Placebo

Intervention Type DRUG

NT 201 Matching-placebo.

Interventions

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NT 201

Clostridium botulinum neurotoxin type A (150 kiloDalton \[kD\], free of complexing proteins) powder for solution for injection.

Intervention Type DRUG

NT 201 Placebo

NT 201 Matching-placebo.

Intervention Type DRUG

Other Intervention Names

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IncobotulinumtoxinA Xeomin/Bocouture Xeomin Cosmetic Xeomeen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No