Glabellar Lines
Conditions
Brief 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
Detailed 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
Interventions
BIOLOGICALJTM201
JTM201 20U in 0.5mL : JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
BIOLOGICALPlacebo
Placebo 20U in 0.5mL : Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Sponsors
Jetema USA Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAE | 180 days | Treatment-emergent AEs (TEAEs) from Baseline through end of followup |
| SAE | 180 days | Serious AEs (SAEs) from the screening period through end of follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glabellar Line Scale (GLS) | 30 days | Proportion of subjects who achieve a ≥ 2-point improvement in GLS at maximum frown by IA and SSA from Baseline |
Countries
United States
Outcome results
None listed