The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
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.
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, Illinois, United States
Measurement of Recurrence and Duration of Herpes Labialis Lesions
Days between last injection and outbreak onset \& Days between onset and recurrence
Time frame: 12 months
Measurement of Lesion Size
Lesions will be measured in millimeters across the maximal lesion length in mm
Time frame: 12 months
Pain Assessment
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. Score range is 0-10. Scores closer to 0 signify lower pain levels and scores closer to 10 signify high pain levels
Time frame: During outbreak
Symptom Evaluation
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 ((0) none, (1) mild, (2) moderate, (3) severe). Scores closer to 0 indicate a more favorable outcome.
Time frame: During outbreak
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