Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230867
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2005-09-29
Brief Title:
Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
Sponsor:
Transport Pharmaceuticals
Organization:
Transport Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 screeningrandomization visit will be randomized in a 111 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None