NCT03970876

Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: EuBiologics Co.,Ltd · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).

Conditions

• Moderate to Severe Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	ATGC-100	Clostridium Botulinum Type A
BIOLOGICAL	Botox®	Clostridium Botulinum Type A

Timeline

• Start date: 2019-04-19
• Primary completion: 2019-09-11
• Completion: 2019-12-23
• First posted: 2019-06-03
• Last updated: 2021-03-23

Locations

1 site across 1 country: South Korea