Herpes Simplex Labialis (HSL) MedDRA version: 8.1 Level: LLT Classification code 10019942 Term: Herpes labialis
Conditions
Interventions
Product Name: Brivudin 0.5% cream
Pharmaceutical Form: Cream
INN or Proposed INN: INN.L29.D
CAS Number: 69304-47-8
Current Sponsor code: Brivudin
Other descriptive name: Brivudin, (E)-5-(2-Bromoetheny
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to investigate the efficacy of repeated topical applications of brivudin cream 0.5% and 1.0% versus placebo cream in the treatment of HSL as measured by the duration of the HSL episode, defined as time from start of treatment to: a) Complete loss of hard crusts in classical HSL lesions. b) Time to resolution of sign(s) and symptom(s) in aborted lesions (defined as lesions not developing beyond the papula stage). ;Secondary Objective: Secondary objectives of the study include the following evaluations: a) The efficacy of brivudin cream 0.5% and 1.0% as measured by: The occurence/proportion of aborted lesions (defined as lesions not developing beyond the papule stage). Time to complete resolution of pain and/or discomfort. Time to resolution of all sign(s) and symptom(s). b) The potential for systemic absorption of BVDU after repeated topical applications of brivudin cream 0.5% and 1.0% (pharmacokinetic measurement of BVDU and BVU plasma levels will be performed at baseline and after 4 days of treatment). c) The potential inhibition of DPD enzyme activity after repeated topical applications of brivudin cream 0.5% and 1.0% (measurement of DPD activity will be performed at baseline and after 4 days of treatment). d) The safety and tolerability of brivudin cream 0.5% and 1.0%. ;Primary end point(s): Duration of the HSL episode defined as time from start of treatment to: a) complete loss of hard crusts in classical HSL lesions and b) time to resolution of sign(s) and symptom(s) in aborted lesions (defined as lesions not developing beyond the papule stage). | — |
Countries
Germany
Outcome results
None listed