Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
Status:
Completed
Trial end date:
2017-10-16
Target enrollment:
Participant gender:
Summary
Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess
pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative
lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or
Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject
within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of
herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4
days.
After self-initiation of treatment with trial medication subjects will be assessed daily by
the Investigator until complete healing for a maximum of 13 days.
Subjects will document application of trial medication and the status of their lesion in a
diary. There will also be blood sampling, ECG measurement and physical examination performed
at the investigational site.