NCT02871492

Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes

A Randomized, Double-blind, Multi-center, Three Arm (Pritelivir, Placebo and Zovirax®) Parallel Group, Comparative Trial to Assess the Efficacy and Safety of Pritelivir 5% w/w Ointment for the Treatment of Recurrent Herpes Labialis in Adults - LipP1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: AiCuris Anti-infective Cures AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	Pritelivir 5% w/w ointment
DRUG	Pritelivir ointment matching placebo
DRUG	Zovirax® cream

Timeline

• Start date: 2016-11-29
• Primary completion: 2017-09-29
• Completion: 2017-10-16
• First posted: 2016-08-18
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

10 sites across 1 country: United States