Herpes Labialis Clinical Trial
Official title:
Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.
A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).
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 0.05% 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 0.05% 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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