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®
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Study Overview
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®
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported