20
Participants
Start Date
August 31, 2010
Primary Completion Date
May 31, 2012
Study Completion Date
June 30, 2012
onabotulinumtoxinA
Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
Bacteriostatic normal saline
Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
DeNova Research, Chicago
Lead Sponsor
Collaborators (1)
Allergan
INDUSTRY
DeNova Research
OTHER