Ablon Skin Institute & Research Center
Manhattan Beach, California, 90266, United States
NCT Number: NCT06246552
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Manhattan Beach, California, 90266, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JTM201 20U in 0.5mL
: JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Placebo 20U in 0.5mL
: Placebo will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location
Time frame: 180 days
Treatment-emergent AEs (TEAEs) from Baseline through end of followup
Time frame: 180 days
Serious AEs (SAEs) from the screening period through end of follow-up
Time frame: 30 days
Proportion of subjects who achieve a ≥ 2-point improvement in GLS at maximum frown by IA and SSA from Baseline
Jetema USA Inc.
Industry
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
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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