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Longitudinal Evaluation and Real-world Evidence of NT201

Sponsor
Merz North America, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05222607
Collaborator
(none)
250
Enrollment
52
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Facial treatment with incobotulinumtoxinA in treatment naïve participants

Drug: IncobotulinumtoxinA
IncobotulinumtoxinA injections for aesthetic indications.
Other Names:
  • XEOMIN®
  • BOCOUTURE®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change [Up to 3 years]

      Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.

    Secondary Outcome Measures

    1. Assessment of FACE-Q Satisfaction with Decision Scale mean change [Up to 3 years]

      Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Satisfaction with Decision Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merz North America, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merz North America, Inc.
    ClinicalTrials.gov Identifier:
    NCT05222607
    Other Study ID Numbers:
    • M602011076
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    incobotulinumtoxinA

    Study Results

    No Results Posted as of Feb 3, 2022