A Phase I/II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Systemic Absorption and Dihydropyrimidine Dehydrogenase (DPD) Enzyme Activity Following Repeated Topical Applications of Brivudin Cream 0.5% and 1.0% in Patients with Herpes Simplex Labialis (HSL)
- Conditions
- Herpes Simplex Labialis (HSL)MedDRA version: 8.1Level: LLTClassification code 10019942Term: Herpes labialis
- Registration Number
- EUCTR2006-002213-13-DE
- Lead Sponsor
- Menarini Ricerche S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
•Male and female Caucasian otherwise healthy HSL patients, >= 18 years of age.
•Clinically diagnosed HSL lesion meeting the following criteria:
a)Early lesion stage, i.e. prodromi, erythema, papule, or the vesicular stage (within 48 hours after onset of the first sign and/or symptom).
b) Location on the lips, the vermilion border, or the perioral skin.
•Willingness to avoid use of topical perioral protectants, lip balms, cosmetics, and over-the-counter products (OTC) or prescription treatments for cold sores during the study.
•Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Evidence of congenital, acquired, or drug-induced immuno-deficiency including any malignancy.
•History of allergy or hypersensitivity to brivudin.
•Any use of local or systemic antivirals or immune-modifying therapy (e.g. corticosteroids, anticancer drugs) within 3 weeks prior to start of treatment.
•History of congenital or acquired DPD deficiency.
•History of complications of herpes simplex infection including central nervous system and ophthalmologic complications, visceral or cutaneous dissemination.
•Patients considered unreliable or unable to follow protocol requirements.
•Concomitant diseases which could have a relevant impact on study results.
•Pregnancy or lactation in female patients.
•Participation in other clinical trials within 4 weeks before enrolment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method