NCT01791881

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

Double-blinded, Randomized, Active Control Comparative, Parallel-designed, Phase III Clinical Trial: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." In Essential Blepharospasm Running Parallel With Phase I Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Hugel · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA

Conditions

• Essential Blepharospasm

Interventions

Type	Name	Description
DRUG	Hugeltox	1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person
DRUG	Botulinum Toxin Type A(Botox®)	1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2013-02-15
• Last updated: 2013-02-15

Locations

9 sites across 1 country: South Korea