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
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02483182 -
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
|
Phase 2 | |
Completed |
NCT03310294 -
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis
|
N/A | |
Terminated |
NCT04539483 -
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
|
Phase 2 | |
Completed |
NCT02265913 -
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
|
Phase 3 | |
Completed |
NCT01971385 -
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
|
Phase 1 | |
Active, not recruiting |
NCT01695187 -
NB-001 Treatment of Recurrent Herpes Labialis
|
Phase 3 | |
Completed |
NCT00375570 -
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
|
Phase 3 | |
Completed |
NCT02871492 -
Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
|
Phase 2 | |
Completed |
NCT01484067 -
Study of a Cold Sore Patch for the Treatment of Herpes Labialis
|
N/A | |
Completed |
NCT00769314 -
Phase 3 Clinical Study for the Treatment of Cold Sore
|
Phase 3 | |
Completed |
NCT00878072 -
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
|
Phase 2/Phase 3 | |
Completed |
NCT01574612 -
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
|
Phase 3 | |
Completed |
NCT03661541 -
Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)
|
Phase 1 | |
Recruiting |
NCT01306084 -
Viral Infections in Healthy and Immunocompromised Hosts
|
||
Terminated |
NCT03521479 -
A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
|
Phase 2 | |
Terminated |
NCT00913692 -
A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
|
Phase 2 | |
Completed |
NCT02207881 -
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
|
Phase 2 | |
Completed |
NCT01653509 -
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
|
Phase 1 | |
Completed |
NCT00361881 -
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
|
Phase 3 | |
Recruiting |
NCT02582086 -
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
|
N/A |