Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis - Full Text View

Sponsor:	University of Utah
Collaborator:	GlaxoSmithKline
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00297011

Purpose

A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).

Condition	Intervention	Phase
Herpes Labialis	Drug: valacyclovir+clobetasol gel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores

Drug Information available for: Clobetasol Clobetasol propionate Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by University of Utah:

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

Estimated Enrollment:	300
Study Start Date:	September 2004
Study Completion Date:	January 2008
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297011

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

GlaxoSmithKline

Investigators

Principal Investigator:

Christopher Hull, MD

University of Utah

More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Jan 8.

Responsible Party:	University of Utah ( Christopher Hull )
Study ID Numbers:	50301066
Study First Received:	February 23, 2006
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00297011 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Herpes Simplex
Mouth Diseases
Anti-Infective Agents
Skin Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiviral Agents
Hormones
Glucocorticoids
Lip Diseases

Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Skin Diseases, Viral
Clobetasol
Valacyclovir
Skin Diseases, Infectious
Therapeutic Uses
DNA Virus Infections
Stomatognathic Diseases
Herpes Labialis

ClinicalTrials.gov processed this record on February 08, 2010