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ISRCTN
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ISRCTN83097613
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ClinicalTrials.gov identifier
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Public title
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Study of the Safety and Efficacy of an Iontophoretic Device to Treat Recurrent Herpes Labialis
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Scientific title
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Acronym
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N/A
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Serial number at source
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COMIRB Protocol 02-925
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Study hypothesis
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To determine the tolerability, safety, and efficacy of an iontophoretic device (ID) that will deliver silver ions to the skin at the site of impending or established recurrent oral herpes simplex virus (HSV) versus the modified control device.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Recurrent herpes
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Participants - inclusion criteria
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1. Age 18 years or greater
2. Peri-oral HSV occurring four or more times per year
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Participants - exclusion criteria
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1. No serious medical illness
2. No use of systemic immunosuppressive therapy
3. No significant dermatological illness on the face
4. No known allergy to metal ions or components of the electrolyte ointment
5. No antiviral therapy in the 7 days prior to an outbreak and during the outbreak
6. Must forego other treatments for HSV during an outbreak
7. Must forego use of lipstick or other emollients to cover a peri-oral HSV lesion
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Anticipated start date
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22/07/2003
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Anticipated end date
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27/07/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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13
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Interventions
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In this study, 13 subjects with a history of herpes labialis used both a test and a placebo device in two separate episodes in order to treat HSV lesions. The stages of the lesions were frequently assessed by the clinician and the subjects. Additionally, the subjects assessed their pain levels. The data were analysed using a paired t-test.
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Primary outcome measure(s)
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Reduction in the time until the cessation of pain and reduction in the time until healed lesion healed.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Klearsen Corporation (USA)
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Trial website
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Publications
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Contact name
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Dr
Steven R
Frank
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Address
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Klearsen Corporation
Research Department
3125 Sterling Circle
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City/town
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Boulder
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Zip/Postcode
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CO 80303
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Country
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United States of America
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Sponsor
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Klearsen Corporation (USA)
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Address
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3125 Sterling Circle
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City/town
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Boulder
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Zip/Postcode
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CO 80303
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Country
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United States of America
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Tel
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+1 303-443-8700
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Email
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info@klearsen.com
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Sponsor website:
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http://www.klearsen.com/index.html
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Date applied
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14/09/2005
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Last edited
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18/08/2011
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Date ISRCTN assigned
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29/09/2005
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