Reccurent Herpes Labialis Clinical Trial
Official title:
The Safety, Efficacy and Convenience of Use of the Natural Agent "Superlysin Gel" as Treatment for Herpes Labialis in Comparison to Acyclovir 5% and Docozanole 10%.
Recurrent cold sores - herpes simplex labialis (HSL) occurs in 20-40% of the US population and patient seek treatment because of the discomfort and visibility of the lesion although it is a self limiting disease. The purpose of this study is to check the safety, Efficacy and convenience of Use of the Natural Agent "Superlysin Gel" as Treatment for Herpes Labialis in Comparison to Acyclovir 5% and Docozanole 10%.
Study design:
-Double blinded non-inferiority prospective parallel-group, intend to treat trial. Enrolment
of 75 patients (25 randomized for each group). - Approval of the Institutional Ethical
Review Board -
Study design:
- Patient characteristics (selected) and historical information assessment including: Race,
average episode duration from patient history Duration of most recent previous episode Time
since last onset of oral-facial herpes simplex Time since first onset of oral-facial herpes
simplex Does patient experience localized prodrome?
- Experiment duration; 5 to 10 days
- 4 visits (days 1, 3,6,10)
- 5 application /day for each derivative
- Documentation Metric digital images of localized area signs at each visit Clinical
assessment of prodrome/erythema, papule, vesicle, ulcer, crust, or healed skin (with or
without residual erythema) Visual analogue scale (VAS) for subjective assessment of
pain, burning, itching or tingling at each visit
- Calculation of primary efficacy end point (time to healing); from the date and time of
the initiation of therapy until the date and time of the clinic visit at which complete
resolution of all local signs and symptoms, i.e. the lesion had aborted or complete
healing had occurred (censored at day 10)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment