Herpes Labialis Clinical Trial
Official title:
Valacyclovir+Temovate Gel for the Episodic Treatment of Herpes Labialis: A Patient-Initiated Double-Blind, Placebo-Controlled Study, Randomized Study.
Verified date | April 2008 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).
Status | Completed |
Enrollment | 300 |
Est. completion date | January 2008 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy variable is the maximum size of the primary lesion complex | |||
Secondary | 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 |
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