Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabella… (NCT06246552) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines
United States480 participantsStarted 2024-10-26
Plain-language summary
This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines
Who can participate
Age range
18 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:
* Subjects ≥18 years of age based on the date of the written informed consent form.
* Subject is able to provide written informed consent and comply with study procedures.
* Subject has moderate or severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS (score of 2 or 3).
Exclusion Criteria:
* Previous insertion of permanent material in the glabellar area including the forehead.
* Planned treatment with botulinum toxin of any serotype in any other body region during the study period.
* Pregnant or breastfeeding (directly or via pump); or planning to become pregnant during the study.
* Known allergy or hypersensitivity to botulinum toxin or product excipients.
* Participation in another interventional clinical study ≤30 days of Visit 1: Screening.
* Planning to donate, bank, or retrieve eggs (ova, oocytes) or donate sperm during the study.
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.