Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: GlaxoSmithKline
• Treatments: Acyclovir; Clobetasol; Valacyclovir

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.