- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467662
Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)
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%.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Doron J Aframian, DMD, PhD
- Phone Number: 0097226776151
- Email: Daframian@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Reducing healing process and duration of cold sores using superlysin gel
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 376.hmo-ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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