Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

Completed · Phase 2

Conditions studied: Herpes Labialis

In brief

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

Key facts

Study ID

NCT00297011

Run by

University of Utah

People needed

300

Starts

2004-09-01

Expected to finish

2008-01-01

Last updated by the study team

2008-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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