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

Reccurent Herpes Labialis Clinical Trial

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%.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00467662
• Other study ID #: 376.hmo-ctil
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 17, 2007
• Last updated: April 30, 2007

Study information

• Verified date: April 2007
• Source: Hadassah Medical Organization
• Contact: Doron J Aframian, DMD, PhD
• Phone: 0097226776151
• Email: Daframian[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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%.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Labialis
• Reccurent Herpes Labialis

Intervention

Drug:
• Acyclovir 5%

• Docosanol 10%

Device:
• Superlysine gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing healing process and duration of cold sores using superlysin gel