Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

Glabellar Frown Lines Clinical Trial

Official title:

A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485601
• Other study ID #: MT-GPRT-GL01
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2011
• Est. completion date: August 17, 2012

Study information

• Verified date: July 2023
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 17, 2012
• Est. primary completion date: March 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
• Women of childbearing potential must have a negative serum pregnancy test at screening

Exclusion Criteria:

• Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
• Patients with an anaphylactic response history to botulinum toxin type A.
• Patients who have been administered botulinum toxin type A within the previous 6 months.
• Pregnant or lactating women.
• Participation in any research study involving drug administration within 90 days preceding enrollment.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• MT10109
Single dose intramuscular injection MT10109 vs Botox®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.	Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).	at Day 30