Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00297011
Other study ID # 50301066
Secondary ID
Status Completed
Phase Phase 2
First received February 23, 2006
Last updated April 30, 2008
Start date September 2004
Est. completion date January 2008

Study information

Verified date April 2008
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2008
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or older.

- A history typical for recurrent herpes labialis. The subject must have experienced three or more cold sores in the last 12 months.

- In general good health, without other serious medical conditions, as determined by the patient's account of his/her medical history.

- Signature on the informed consent document.

Exclusion Criteria:

- Patients who have participated in an investigational drug study in the four-week period prior to enrollment.

- Previous herpes vaccine at any time.

- Patients with major medical conditions such as chronic heart, pulmonary, renal or hepatic diseases.

- Patients with immunodeficiency disorders such as HIV infection or cancer chemotherapy.

- Patients using topical steroids on or near the face or systemic steroids within 30 days of enrollment.

- Women who are pregnant, lactating or breast feeding.

- Women of childbearing potential not using adequate contraception as judged by the Investigator.

- Recent history of alcohol or drug abuse, which in the opinion of the investigator, may interfere with that study patient's compliance with study requirements.

- Significant skin disease such as atopic dermatitis, acne, or rosacea that would interfere with the assessment of lesions.

- Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues.

- Subjects with impaired renal function as defined as a serum creatinine above the upper limits of normal.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
valacyclovir+clobetasol gel


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary efficacy variable is the maximum size of the primary lesion complex
Secondary Secondary variables include: the proportion of primary lesions that are aborted; the mean time to healing of the primary lesion complex the frequency and mean duration of lesion pain among primary lesions; the frequency of secondary lesions
See also
  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