Botulinum Toxin A for Herpes Labialis

NATerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

May 31, 2012

Study Completion Date

June 30, 2012

Conditions
Herpes Labialis
Interventions
DRUG

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.

OTHER

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.

Trial Locations (1)

60611

DeNova Research, Chicago

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

DeNova Research

OTHER