Longitudinal Evaluation and Real-world Evidence of NT201

June 5, 2023 updated by: Merz North America, Inc.

LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Arlington, Virginia, United States, 22209
        • SkinDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female participants, 18 years of age or older, seeking treatment with incobotulinumtoxinA for UFL in the North American, Latin American, European, and Asia-Pacific regions.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Facial treatment with incobotulinumtoxinA in treatment naïve participants
Drug: IncobotulinumtoxinA
IncobotulinumtoxinA injections for aesthetic indications.
Other Names:
  • XEOMIN®
  • BOCOUTURE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
Time Frame: 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.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of FACE-Q Satisfaction with Decision Scale mean change
Time Frame: 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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M602011076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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