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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-26

Study Completion Date

2025-06-05

Brief Summary

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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

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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

Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JTM201

Botulinum toxin

Group Type EXPERIMENTAL

JTM201

Intervention Type BIOLOGICAL

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Placebo

Placebo 20U in 0.5mL

: Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jetema USA Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ablon Skin Institute & Research Center

Manhattan Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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J-001-US

Identifier Type: -

Identifier Source: org_study_id

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