CompletedPhase 2

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

Australia121 participantsStarted 2011-12-07

Plain-language 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®

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.

Timeframe: at Day 30

Trial details

NCT IDNCT01485601

SponsorMedy-Tox

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03-30

Results submitted2022-08-02

View on ClinicalTrials.gov More Glabellar Frown Lines trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.