Status:
UNKNOWN
Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Reccurent Herpes Labialis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 limit...
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 Revie...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00467662
Last Update
May 1 2007
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.