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

NCT02871492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2021-07-13

Study results available
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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

DRUG

Pritelivir 5% w/w ointment

DRUG

Pritelivir ointment matching placebo

DRUG

Zovirax® cream

Sponsors & Collaborators

  • Novella Clinical

    collaborator OTHER

  • AiCuris Anti-infective Cures AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2017-09-29
Completion
2017-10-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871492 on ClinicalTrials.gov