Study of the Safety and Efficacy of an Iontophoretic Device to Treat Recurrent Herpes Labialis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Steven R Frank
Scientific

Klearsen Corporation
Research Department
3125 Sterling Circle
Boulder
CO 80303
United States of America

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	Reduction in the time until the cessation of pain and reduction in the time until healed lesion healed.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	27/07/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	13
Key inclusion criteria	1. Age 18 years or greater 2. Peri-oral HSV occurring four or more times per year
Key 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
Date of first enrolment	22/07/2003
Date of final enrolment	27/07/2004

Klearsen Corporation

Boulder
CO 80303
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan