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

JETEMA

Status and phase: Not yet enrolling; Phase 2

Conditions: Glabellar Lines

Treatments: Biological: Placebo; Biological: JTM201

Study type: Interventional

Funder types: Industry

Identifiers

NCT06246552

J-001-US

Details and patient eligibility

About

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

Full 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

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

JTM201

Experimental group

Description:

Botulinum toxin

Treatment:

Biological: JTM201

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo