Genito-anal herpes simplex infections
Conditions
Interventions
Product Name: Betadexum / Cyclodextrin Gel
Product Code: 2-HP-BCD (2-Hydroxylpropyl-ß-cyclodextrin
Pharmaceutical Form: Gel
INN or Proposed INN: Betadexum
Other descriptive name: Cyclodextrin
Concentr
Sponsors
Spirig Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Medically confirmed diagnosis of recurrent genital herpes (Herpes simplex) Diameter of lesion =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Malignant diseases, Diabetes mellitus type 1, Clinically relevant renal impairment, Concomitant therapy with immunosuppressive drugs, Systemic antiviral therapy within 7 days prior to randomisation and during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the effect of cyclodextrin gel on the duration to crusting of vesicles;Secondary Objective: Assessment of the duration to cessation of pain caused by the herpes infection, assessment of the duration to cessation of new vesicles, assessment of the reduction of the herpetic lesion size, assessment of the duration to lesion healing, patients assessment of study treatment and previously used antiviral drug, assessment of the tolerability, clinical assessment of the severity of the herpetic skin reaction.;Primary end point(s): Duration to crusting of vesicles. | — |
Countries
Germany
Outcome results
None listed