60
Participants
Start Date
October 31, 2005
Primary Completion Date
February 28, 2006
Study Completion Date
August 31, 2006
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.
Sang Yeul Lee, Seoul
Lead Sponsor
Pacific Pharmaceuticals
INDUSTRY