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 个研究点目标入组 100 人开始时间: 2006年8月11日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•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.

发起方

Menarini Ricerche S.p.A.