Longitudinal Evaluation and Real-world Evidence of NT201

Terminated

• Conditions: Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
• Interventions: Drug: IncobotulinumtoxinA

• Registration Number: NCT05222607
• Lead Sponsor: Merz North America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Study Start: 2023-02-10
• Primary Completion: 2023-05-18
• Study Completion: 2023-05-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Facial treatment with incobotulinumtoxinA in treatment naïve participants	IncobotulinumtoxinA	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

SkinDC; 🇺🇸 Arlington, Virginia, United States