NCT05531968

Treatment of Moderate to Severe Glabellar Lines (BMI2006)

Multicenter, Double-blind, Randomized, Parallel Design, Active-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of 100 Units of BMI 2006 and Botox® in Adult Patients in Need of Moderate or Severe Glabellar Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: BMI Korea · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult patients in need of moderate or severe glabellar lines

Detailed description

Purpose of clinical trial: The purpose of this study was to evaluate the efficacy and safety of 20U dose administration of 100 units of BMI2006 in adult patients who needed moderate or severe glabellar lines. primary purpose Comparing the effectiveness after administration of each 20U dose of 'BMI2006 100 Units' or 'Botox® Week' for adult patients in need of moderate or severe glabellar lines, it was found that the BMI2006 injection group was non-inferior to the Botox® injection group. wanted to confirm. secondary purpose The purpose of this study was to evaluate the safety and effectiveness of 'BMI2006 100 Units' 20U compared to 'Botox® Injection' 20U for adult patients who need moderate or severe glabellar wrinkles. This clinical trial was designed as a multicenter, double-blind, randomized, parallel design, active-controlled Phase 3 clinical trial, and was intended for patients with moderate or severe glabellar lines. Only those subjects who have agreed in writing to voluntarily participate in the clinical trial and who are evaluated to meet the selection/exclusion criteria are 1:1 to the test group (BMI2006 week administration group) or control group (Botox®) in the order of participation in the clinical trial was randomly assigned. Subjects assigned with randomization numbers were intramuscularly injected (IM) with a total of 20U of clinical trial drugs in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Thereafter, at 4, 8, 12, and 16 weeks at intervals of 4 weeks, the institution was visited to evaluate the efficacy and safety for a total of 16 weeks.

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	BMI2006	IM
BIOLOGICAL	BOTOX®	IM

Timeline

• Start date: 2021-02-09
• Primary completion: 2021-08-10
• Completion: 2021-09-17
• First posted: 2022-09-08
• Last updated: 2022-09-08

Locations

3 sites across 1 country: South Korea