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

Sponsored by Jetema USA Inc.

About this trial

Last updated 9 months ago

Study ID

J-001-US

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18+ Years
All Sexes

Trial Timing

Ended a year ago

What is this trial 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

What are the participation requirements?

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.