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Completed

NCT Number: NCT06246552

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. TEAE

    Time frame: 180 days

    Treatment-emergent AEs (TEAEs) from Baseline through end of followup

  2. SAE

    Time frame: 180 days

    Serious AEs (SAEs) from the screening period through end of follow-up

Other outcomes

  1. Glabellar Line Scale (GLS)

    Time frame: 30 days

    Proportion of subjects who achieve a ≥ 2-point improvement in GLS at maximum frown by IA and SSA from Baseline

Sponsors and collaborators

Lead sponsor

Jetema USA Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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