EUCTR2006-002213-13-DE
Active, not recruiting
Phase 1
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)
Menarini Ricerche S.p.A.0 sites100 target enrollmentAugust 11, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Herpes Simplex Labialis (HSL)
- Sponsor
- Menarini Ricerche S.p.A.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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