Longitudinal Evaluation and Real-world Evidence of NT201

NCT05222607 | Terminated FDA Drug

• 1 other identifier: M602011076
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change

  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 Outcomes (1)

• Assessment of FACE-Q Satisfaction with Decision Scale mean change

  Up to 3 years

Study Arms (1)

Facial treatment with incobotulinumtoxinA in treatment naïve participants

Drug: IncobotulinumtoxinA

Interventions

IncobotulinumtoxinA DRUG

IncobotulinumtoxinA injections for aesthetic indications.

Also known as: XEOMIN®, BOCOUTURE®

Facial treatment with incobotulinumtoxinA in treatment naïve participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older.
• Planning treatment with incobotulinumtoxinA.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (1)

SkinDC

Arlington, Virginia, 22209, United States

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 3, 2022
• Study Start: February 10, 2023
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

US (1)