Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis) - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00467662

Purpose

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	Intervention	Phase
Reccurent Herpes Labialis	Drug: Acyclovir 5% Drug: Docosanol 10% Device: Superlysine gel	Phase IV

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
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%.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Reducing healing process and duration of cold sores using superlysin gel

Estimated Enrollment:

75

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)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467662

Contacts

Contact: Doron J Aframian, DMD, PhD

0097226776151

Daframian@yahoo.com

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

More Information

Study ID Numbers:	376.hmo-ctil
Study First Received:	April 17, 2007
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00467662
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Mouth Diseases
Virus Diseases
Herpes Simplex
Skin Diseases, Infectious
Acyclovir

Skin Diseases
DNA Virus Infections
Stomatognathic Diseases
Herpesviridae Infections
Herpes Labialis

Additional relevant MeSH terms:

Skin Diseases, Viral
Anti-Infective Agents
Therapeutic Uses

Antiviral Agents
Lip Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009