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
• Interventions: Biological: JTM201; Biological: Placebo

• 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

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-08
• Study Start: 2024-03-25
• Primary Completion: 2024-10-31
• Study Completion: 2025-03-15

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

Arm && Interventions

Group	Intervention	Description
JTM201	JTM201	Botulinum toxin
Placebo	Placebo	Placebo

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