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

Launched by JETEMA USA INC. · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called JTM201 for people who have moderate to severe glabellar lines, which are the wrinkles that form between your eyebrows when you frown. The study aims to see if this treatment is safe and effective in reducing those lines. It will be conducted at multiple locations, and participants will receive either the JTM201 treatment or a placebo (a treatment that looks the same but has no active ingredients) without knowing which one they got.

To join the study, participants need to be at least 18 years old and have noticeable glabellar lines. However, some people won't be eligible, such as those who have had certain types of treatments in that area before or who are pregnant or breastfeeding. The trial is not currently recruiting participants, but once it does, those who qualify will receive information about what to expect during the study, including any visits for assessments and how the treatment will be given. Overall, this trial hopes to find a new way to help reduce the appearance of these wrinkles and improve people's confidence.

Gender

ALL

Eligibility criteria

• 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.