NCT01225341

Botulinum Toxin A for Herpes Labialis

A Double-Blind, Randomized, Placebo Controlled, Crossover Study to Assess the Safety and Efficacy of Botulinum Toxin A Injections as a Preventative Measure for Herpes Labialis.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: DeNova Research · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2010-10-21
• Last updated: 2020-12-21
• Results posted: 2020-12-21

Locations

1 site across 1 country: United States