Phase 2
Completed N=121
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
Glabellar Frown Lines
Source: ClinicalTrials.gov NCT01485601 ↗
Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Feb 2024
Primary outcomePrimary: Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. — 18; 18; 22; 19 Participants
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®
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. |
18; 18; 22; 19; 12; 8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01485601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.