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

Glabellar Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06246552
• Other study ID #: J-001-US
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: February 2024
• Source: Jetema USA Inc.
• Contact: Jongwoo Kim, MSc
• Phone: +827043373927
• Email: jwkim0223[@]jetema.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: March 15, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jetema USA Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	TEAE	Treatment-emergent AEs (TEAEs) from Baseline through end of followup	180 days
Primary	SAE	Serious AEs (SAEs) from the screening period through end of follow-up	180 days