Reccurent Herpes Labialis | Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)
Reccurent Herpes Labialis research study
What is the primary objective of this study?
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%.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Reccurent Herpes Labialis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Phase: Phase 4
Primary Outcome: Reducing healing process and duration of cold sores using superlysin gel
Study sponsors, principal investigator, and references
Principal Investigator: Doron Aframian, DMD,PhD
Lead Sponsor: Hadassah Medical Organization