Clinical Trial: Botulinum Toxin A for Herpes Labialis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: DeNova Research

Current Primary Outcome: Efficacy [ Time Frame: 3 months post injection ]

Efficacy is the primary response variable for this study and therefore will be evaluated at each visit from facial injection through 24-months post baseline injection visit as described below:

  • Measurement of recurrence and duration of herpes labialis lesions
  • Onset and stop dates for recurrent episodes of herpes labialis will be recorded and transcripted from the information recorded on the subject's diary and collected at each scheduled visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measurement of Lesion Size [ Time Frame: During outbreak ]
    Upon recurrence of herpes labialis subject will return to site for measurement of lesion(s). Lesion will be measured in millimeters across the maximal lesion length.
  • Pain Assessment [ Time Frame: During outbreak ]
    Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to the Visual Analog Scale for pain (VAS) by placing a straight line intersecting the pain line. The scale will be 10 cm long and the distance from start to mark will be measured in millimeters
  • Symptom Evaluation [ Time Frame: During outbreak ]
    Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to a 4-point scale (none, mild, moderate, severe).


Original Secondary Outcome: Same as current

Information By: DeNova Research

Dates:
Date Received: October 19, 2010
Date Started: August 2010
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015