Study of the Safety and Efficacy of an Iontophoretic Device to Treat Recurrent Herpes Labialis
| ISRCTN | ISRCTN83097613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83097613 |
| Secondary identifying numbers | COMIRB Protocol 02-925 |
- Submission date
- 14/09/2005
- Registration date
- 29/09/2005
- Last edited
- 18/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Steven R Frank
Scientific
Scientific
Klearsen Corporation
Research Department
3125 Sterling Circle
Boulder
CO 80303
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 22/07/2003 |
| Overall study end date | 27/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 13 |
| Participant inclusion criteria | 1. Age 18 years or greater 2. Peri-oral HSV occurring four or more times per year |
| 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
Study participating centre
Klearsen Corporation
Boulder
CO 80303
United States of America
CO 80303
United States of America
Sponsor information
Klearsen Corporation (USA)
Industry
Industry
3125 Sterling Circle
Boulder
CO 80303
United States of America
| Phone | +1 303-443-8700 |
|---|---|
| info@klearsen.com | |
| Website | http://www.klearsen.com/index.html |
Funders
Funder type
Industry
Klearsen Corporation (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
