Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines
NCT ID: NCT06246552
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
480 participants
INTERVENTIONAL
2024-10-26
2025-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JTM201
Botulinum toxin
JTM201
JTM201 20U in 0.5mL
: JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Placebo
Placebo
Placebo
Placebo 20U in 0.5mL
: Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Interventions
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JTM201
JTM201 20U in 0.5mL
: JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Placebo
Placebo 20U in 0.5mL
: Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jetema USA Inc.
INDUSTRY
Responsible Party
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Locations
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Ablon Skin Institute & Research Center
Manhattan Beach, California, United States
Countries
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Other Identifiers
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J-001-US
Identifier Type: -
Identifier Source: org_study_id
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