Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
COMIRB Protocol 02-925
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Recurrent herpes
Intervention
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.
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measures
Reduction in the time until the cessation of pain and reduction in the time until healed lesion healed.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/07/2003
Overall trial end date
27/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 years or greater
2. Peri-oral HSV occurring four or more times per year
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
13
Participant exclusion criteria
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
Recruitment start date
22/07/2003
Recruitment end date
27/07/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
Klearsen Corporation
Boulder
CO 80303
United States of America
Sponsor information
Organisation
Klearsen Corporation (USA)
Sponsor details
3125 Sterling Circle
Boulder
CO 80303
United States of America
+1 303-443-8700
info@klearsen.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Klearsen Corporation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary