Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

February 28, 2006

Study Completion Date

August 31, 2006

Conditions
Blepharospasm
Interventions
DRUG

Korean Botulinum toxin type A (KbtxA) and Botox injection

Each vial of Botox and KbtxA contained 100 U of BTX-A in a sterile vacuum-derived form without preservatives. Each vial of KbtxA was identical to the placebo (Botox) vial, and all vials were reconstituted with 2.0 mL of 0.9% sterile nonpreserved saline solution to a final dilution of 5 U /0.1 mL. The dose of BTX-A per injection site was 2.5 U to 5 U, and the location, number of injection sites. Using a 30-gauge needle, injections were angled away from the center of lid to reduce the risk of spread into the levator muscle. Injection sites include the upper medial and lateral eyelid margins, lower lateral lid margins, and above the eyebrow.

Trial Locations (1)

120-752

Sang Yeul Lee, Seoul

Sponsors
All Listed Sponsors
lead

Pacific Pharmaceuticals

INDUSTRY

NCT00682760 - Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm | Biotech Hunter | Biotech Hunter