Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis
Information source: University of Utah
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Labialis
Intervention: valacyclovir+clobetasol gel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Christopher Hull, MD, Principal Investigator, Affiliation: University of Utah
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).
Clinical Details
Official title: Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is the maximum size of the primary lesion complex
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Utah, Salt Lake City, Utah 84132, United States
Additional Information
Starting date: September 2004
Ending date: January 2008
Last updated: April 30, 2008
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