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NCT00430963 Clinical Trial

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Glabellar Frown Lines Clinical Trial

Official title:
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00430963
Other study ID # MRZ 60201-0520/1
Secondary ID
Status Completed
Phase Phase 3
First received February 1, 2007
Last updated October 25, 2011
Start date October 2006
Est. completion date November 2007

Study information
Verified date October 2011
Source Merz Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension [OLEX] Period of 120 days each.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date November 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

- Previous insertion of permanent material in the glabellar area

- Neuromuscular function disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• IncobotulinumtoxinA (Xeomin) (20 Units)

• Placebo

Locations
Country Name City State
Germany Merz Pharmaceuticals GmbH Frankfurt

Sponsors (1)
Lead Sponsor Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator's assessment according to the Facial Wrinkle Scale (FWS) Responder: FWS score of 0 or 1. Day 30 No
Primary Patient's global assessment Responder: subjects with a score of at least 2+. Day 30 No
Secondary Investigator's assessment according to FWS Responder: FWS score of 0 or 1. Day 7, 60, 90, and 120 No
Secondary Patient's global assessment Responder: subjects with a score of at least 2+. Day 7, 60, 90, and 120 No
See also
  Status Clinical Trial Phase
Completed NCT02236312 - Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines Phase 2
Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT05623410 - Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines Phase 3
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Completed NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Completed NCT04143815 - Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT05320393 - Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines Phase 2
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3
Completed NCT01333397 - Safety and Efficacy Study of Dysport RU and Glabellar Lines Phase 2