CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 801 enrolled
Drug / intervention
IncobotulinumtoxinA (Xeomin) (20 units)drug
Likely dose
IncobotulinumtoxinA (Xeomin) (20 units)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00512135
NCT00512135Phase 3Completed
CompareCT.gov

A Prospective, Open-label, Multicenter, Repeat-dose Trial to Investigate the Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Merz Pharmaceuticals GmbH·interventional·Posted Aug 7, 2007·Updated Apr 2, 2021

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA (Xeomin) (20 units) for Glabellar Lines. Completed, enrolled 801 participants across 25 sites in 3 countries.

Detailed Summary

The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Lines
CountriesCanada, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2007
Enrollment StartJun 18, 2007
Primary CompletionDec 28, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.9 years ago

Interventions

IncobotulinumtoxinA (Xeomin) (20 units)drug

Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.