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

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: MT10109

• Registration Number: NCT01485601
• Lead Sponsor: Medy-Tox

Brief 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®

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Study Start: 2011-12-07
• Primary Completion: 2012-03-30
• Study Completion: 2012-08-17
• Results First Submitted: 2022-08-02
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Results First Posted: 2024-02-22
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT10109	MT10109	Clostridium botulinum toxin type A
Botox (registered trade mark)	MT10109	Clostridium botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.	at Day 30	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).