Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
Currently approved drugs for the treatment of herpes labialis (cold sores) exhibit low levels of efficacy due to the limited ability of the drugs to penetrate the skin to the site where the herpes virus is replicating. Iontophoresis uses electric current to enhance the delivery of drugs through the skin. This trial is testing a new iontophoretic device for the delivery of acyclovir cream to treat cold sores.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Placebo Controlled, Randomized, Double Blind, Subject Initiated Study of the Safety and Efficacy of a Single Topical Iontophoretic Application of Acyclovir 5% Cream With an Open Label Conventional Therapy Treatment Arm, and a Blinded Evaluator, for the Treatment of Recurrent Herpes Labialis|
- Clinician assessed duration of the herpetic episode measured from time of treatment until lesion healed. Lesion assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
- Clinician assessed prevention of progression to a classical lesion
- Clinician assessed duration of classical herpetic lesions.
- Clinician assessed duration of the herpetic lesion (aborted lesions will be assigned a duration of lesion value of 0 for the purposes of the statistical analysis).
- Clinician assessed duration of the herpetic lesion hard scab.
- Examine the safety of iontophoretic application of acyclovir 5% cream.
- All assessments for a minimum of 5 consecutive days and a maximum of 10 consecutive days.
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||December 2005|
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of iontophoretically-applied acyclovir 5% cream for the treatment of herpes simplex labialis lesions including an open label arm using Zovirax (acyclovir) Cream 5% as per standard of care in the same patient population. Subjects who meet the eligibility requirements at the screening/randomization visit will be randomized in a 1:1:1 ratio to one of the three treatment groups. After being enrolled and randomized into the study, subjects will be sent home with a locked kit containing the iontophoretic device with either active or placebo cream or a locked kit containing Zovirax Cream 5%. At first signs and/or symptoms of a recurrent herpetic episode (Stage 0 or 1, prodromal or erythema), the lesion will be confirmed by telephone interview with the subject, and upon confirmation of the lesion, the subject will be given the combination to the locked kit and instructed to begin treatment immediately, thereby initiating the Treatment Phase of the study. Subjects will be followed for at least 5 consecutive days post-treatment up until a maximum of 10 consecutive days post-treatment, until the herpes lesion is healed.
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|Principal Investigator:||Christopher M Hull, MD||University of Utah|