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

NCT06246552 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: J-001-US
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Glabellar Line Scale (GLS)

  30 days

Study Arms (2)

JTM201

EXPERIMENTAL

Botulinum toxin

Biological: JTM201

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

JTM201 BIOLOGICAL

JTM201 20U in 0.5mL : JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location

JTM201

Placebo BIOLOGICAL

Placebo 20U in 0.5mL : Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jetema USA Inc.: lead

Study Sites (1)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: October 26, 2024
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)