Condition category
Infections and Infestations
Date applied
14/09/2005
Date assigned
29/09/2005
Last edited
18/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steven R Frank

ORCID ID

Contact details

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

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

http://www.klearsen.com/index.html

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

Publication citations

Additional files

Editorial Notes