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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00467662
First received: April 17, 2007
Last updated: April 30, 2007
Last verified: April 2007

April 17, 2007
April 30, 2007
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Reducing healing process and duration of cold sores using superlysin gel
Same as current
Complete list of historical versions of study NCT00467662 on ClinicalTrials.gov Archive Site
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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%.

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%.

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)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Reccurent Herpes Labialis
  • Drug: Acyclovir 5%
  • Drug: Docosanol 10%
  • Device: Superlysine gel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
75
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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
Both
18 Years to 70 Years
No
Contact: Doron J Aframian, DMD, PhD 0097226776151 Daframian@yahoo.com
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NCT00467662
376.hmo-ctil
Yes
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Hadassah Medical Organization
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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
Hadassah Medical Organization
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP