NCT06246552

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Jetema USA Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-10-26
• Primary completion: 2025-06-05
• Completion: 2025-06-05
• First posted: 2024-02-07
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study