Longitudinal Evaluation and Real-world Evidence of NT201

NCT ID: NCT05222607

Last Updated: 2023-06-07

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

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-10

Study Completion Date

2023-05-18

Brief Summary

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This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.

Detailed Description

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Conditions

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Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Facial treatment with incobotulinumtoxinA in treatment naïve participants

IncobotulinumtoxinA

Intervention Type DRUG

IncobotulinumtoxinA injections for aesthetic indications.

Interventions

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IncobotulinumtoxinA

IncobotulinumtoxinA injections for aesthetic indications.

Intervention Type DRUG

Other Intervention Names

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XEOMIN® BOCOUTURE®

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* Planning treatment with incobotulinumtoxinA.

Exclusion Criteria

* Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
* Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
* Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
* Any infection and/or inflammation at the planned injection points.
* Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SkinDC

Arlington, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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M602011076

Identifier Type: -

Identifier Source: org_study_id

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