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Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

Primary Purpose

Herpes Labialis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valacyclovir+clobetasol gel
Sponsored by
University of Utah
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Labialis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Utah

Outcomes

Primary Outcome Measures

The primary efficacy variable is the maximum size of the primary lesion complex

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2006
Last Updated
April 30, 2008
Sponsor
University of Utah
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00297011
Brief Title
Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis
Official Title
Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valacyclovir+clobetasol gel
Primary Outcome Measure Information:
Title
The primary efficacy variable is the maximum size of the primary lesion complex
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hull, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19143902
Citation
Hull C, McKeough M, Sebastian K, Kriesel J, Spruance S. Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):263-7. doi: 10.1111/j.1468-3083.2008.03047.x. Epub 2009 Jan 8.
Results Reference
derived

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Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

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