Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines
Phase 2
Not yet recruiting
- Conditions
- Glabellar Lines
- Registration Number
- NCT06246552
- Lead Sponsor
- Jetema USA Inc.
- Brief 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
- Detailed Description
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. Treatment period is 180 days and evaluation of the safety is the primary endpoint
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 480
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method SAE 180 days Serious AEs (SAEs) from the screening period through end of follow-up
TEAE 180 days Treatment-emergent AEs (TEAEs) from Baseline through end of followup
- Secondary Outcome Measures
Name Time Method