Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)

Study Overview
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Brief Summary
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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%.

Detailed Description
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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)

Official Title
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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%.

Conditions
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Reccurent Herpes Labialis

Intervention / Treatment
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* Drug: Acyclovir 5%
* Drug: Docosanol 10%
* Device: Superlysine gel


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed informed consent Age range (yrs) 18-70 Gender ; Males and females Health status; immuno-competent Clinical history of HSL with at least two recurrences during the past 12 months. The most recent previous episode must have healed at least 14 days before screening. Less than 12 hours after prodrome initiation (i.e. local erythema w/o blistering, tingling and or burning sensation, soreness) Exclusion criteria: Pregnant women Mentally disabled No intra-oral lesions, or lesions above the nostrils and below the chin No topical steroid use and no systemic antiviral current treatments within 7 days before the study No known allergies to topical cosmetics No use cosmetics on or around the mouth during the treatment period No concomitant use of systemic corticosteroids or other drugs known to induce immune stimulation or immune suppression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Acyclovir 5%|nan|
|Drug: Docosanol 10%|nan|
|Device: Superlysine gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing healing process and duration of cold sores using superlysin gel |  |  |