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Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297011
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : May 6, 2008
Information provided by:
University of Utah

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).

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: valacyclovir+clobetasol gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.
Study Start Date : September 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Primary Outcome Measures :
  1. The primary efficacy variable is the maximum size of the primary lesion complex

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297011

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
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Principal Investigator: Christopher Hull, MD University of Utah

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christopher Hull, University of Utah Identifier: NCT00297011     History of Changes
Other Study ID Numbers: 50301066
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
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Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs