Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines

Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Phase 2 Study of the Safety and Efficacy of JTM201 (Botulinum Toxin Type A) to Treat Moderate or Severe Glabellar Lines

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

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Biological: JTM201; Biological: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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
Experimental: JTM201; Botulinum toxin	Biological: JTM201; JTM201 20U in 0.5mL : JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAE	Treatment-emergent AEs (TEAEs) from Baseline through end of followup	180 days
SAE	Serious AEs (SAEs) from the screening period through end of follow-up	180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glabellar Line Scale (GLS)	Proportion of subjects who achieve a ≥ 2-point improvement in GLS at maximum frown by IA and SSA from Baseline	30 days

Collaborators and Investigators

• Sponsor: Jetema USA Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2024
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 24, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: J-001-US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No