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

Hadassah Medical Center

Status and phase

Unknown

Phase 4

Conditions

Reccurent Herpes Labialis

Treatments

Drug: Acyclovir 5%

Drug: Docosanol 10%

Device: Superlysine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT00467662

376.hmo-ctil

Details and patient eligibility

About

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%.

Full 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)

Enrollment

75 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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