Efficacy and safety of topically applied cyclodextrin gel (Spirig Pharma) in the treatment of recurrent genital herpes simplex virus infections: a randomised, double-blind, placebo-controlled, multicentre trial.

INTERVENTION: 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 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Topical use (Noncurrent) CONDITION: Genito‐anal herpes simplex infections PRIMARY OUTCOME: Main Objective: Assessment of the effect of cyclodextrin gel on the duration to crusting of vesicles Primary end point(s): 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. INCLUSION CRITERIA: Medically confirmed diagnosis of recurrent genital herpes (Herpes simplex) Diameter of lesion < 3 mm, History of 4 to 10 relapses of genital herpes within one year prior to inclusion in the study. 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) no F.1.3.1 Number of subjects for this age range