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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT00467662

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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%.

Condition or Disease	Intervention/Treatment	Phase
Reccurent Herpes Labialis	Drug: Acyclovir 5% Drug: Docosanol 10% Device: Superlysine gel	Phase 4

Detailed Description

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

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%.

Outcome Measures

Primary Outcome Measures

Reducing healing process and duration of cold sores using superlysin gel []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Study Chair: Doron Aframian, DMD,PhD, Salivary Gland Clinic, Department of Oral Medicine The Hebrew University-Hadassah School of Dental Medicine Jerusalem, Israel P.O.B 12272, Zip code 91120