Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297011
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2006-02-23
Brief Title:
ValacyclovirTemovate Gel for the Treatment of Herpes Labialis
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
ValacyclovirTemovate Gel for the Episodic Treatment of Herpes Labialis A Patient-Initiated Double-Blind Placebo-Controlled Study Randomized Study
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized study comparing the combination of valacyclovir and temovate gel clobetasol gel versus placebo for the treatment of recurrent herpes labialis cold sores
Detailed Description:
Herpes simplex labialis is a common worldwide affliction for which neither public health procedures vaccines nor antiviral chemotherapy have had a major impact The present study has been proposed because it has become clear there are marked limitations to the benefit of antiviral therapy in herpes labialis Recently a pilot trial of the combination of famciclovir and topical 005 fluocinonide vs famciclovir alone showed that the addition of corticosteroids to the antiviral drug treatment caused a marked and statistically significant reduction in lesion size and a trend to more aborted lesions
This study is designed as a randomized placebo-controlled patient-initiated study The objective of this study is to evaluate the safety and efficacy of oral valacyclovir 2grams BID for one day and topical temovate 005 gel BID for three days compared to placebo capsules and placebo gel in the episodic treatment of a single episode of recurrent herpes labialis in immunologically normal patients
Subjects will be screened randomized to study drug and instructed to start using study drug within one hour of the first sign or symptom of their next episode of herpes labialis Data on the treated lesion will be collected by clinic visits and a patient diary card
This study is designed as a randomized placebo-controlled patient-initiated study The objective of this study is to evaluate the safety and efficacy of oral valacyclovir 2grams BID for one day and topical temovate 005 gel BID for three days compared to placebo capsules and placebo gel in the episodic treatment of a single episode of recurrent herpes labialis in immunologically normal patients
Subjects will be screened randomized to study drug and instructed to start using study drug within one hour of the first sign or symptom of their next episode of herpes labialis Data on the treated lesion will be collected by clinic visits and a patient diary card
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