Glabellar Lines Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for the Treatment of Moderate to Severe Glabellar Lines
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants. AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04096326 -
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
|
Phase 2 | |
Completed |
NCT02961673 -
The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
|
Phase 1/Phase 2 | |
Completed |
NCT01271452 -
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
|
Phase 4 | |
Completed |
NCT05013424 -
A Study of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
|
Phase 2 | |
Completed |
NCT01189760 -
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
|
Phase 3 | |
Completed |
NCT05100199 -
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines
|
Phase 2 | |
Completed |
NCT03721016 -
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
|
Phase 3 | |
Completed |
NCT04157686 -
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
|
Phase 3 | |
Completed |
NCT02353897 -
Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®
|
||
Completed |
NCT03732833 -
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
|
Phase 3 | |
Completed |
NCT06212960 -
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines
|
Phase 1 | |
Completed |
NCT05089357 -
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
|
||
Completed |
NCT00408785 -
A Study Of BOTOX For The Treatment Of Glabellar Lines
|
Phase 3 | |
Completed |
NCT05380154 -
Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.
|
Phase 3 | |
Completed |
NCT01224015 -
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
|
Phase 3 | |
Completed |
NCT05248880 -
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines
|
Phase 3 | |
Completed |
NCT03216408 -
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines
|
Phase 3 | |
Completed |
NCT05298449 -
Phase 2 of HU-045 in Glabellar Lines
|
Phase 2 | |
Not yet recruiting |
NCT06246552 -
Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines
|
Phase 2 | |
Completed |
NCT05248867 -
A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
|
Phase 3 |