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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Acyclovir; Docosanol

Criteria

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