Status:
COMPLETED
Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis
Lead Sponsor:
University of Utah
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Herpes Labialis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00297011
Start Date
September 1 2004
End Date
January 1 2008
Last Update
May 6 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Utah
Salt Lake City, Utah, United States, 84132