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NCT02871492 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by AiCuris Anti-infective Cures.

Completed
Registry status
Phase 2
Development phase
362
Enrollment target

NCT02871492: Completed Phase 2 study, sponsored by AiCuris Anti-infective Cures.

NCT02871492 is a Phase 2 study that has completed, run by AiCuris Anti-infective Cures. The registered enrollment target is 362 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (172% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02871492, a Phase 2 study, has completed, sponsored by AiCuris Anti-infective Cures.

COMPLETED
Registry status
Phase 2
Development phase
362 participants
Enrollment target

Study 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.

Primary Outcome

The Investigator assessed subjects for lesion stage at every visit as long as lesions were present from Visit 1 to the End of Trial Visit (Day 12± 1) as a maximum. Percentage of subjects with non-ulcerative lesions (i.e, scoring below 3) based on the Principal Investigators Assessment. Lesion stages were defined as follows: 1-Prodrome; 2a-Redness; 2b-Erythema-Redness; 3-Small Blister; 4-Ulcer; 5-Crust; 6-Drying up and healing; 0-Resolved

Interventions

  • DRUG Pritelivir 5% w/w ointment
  • DRUG Pritelivir ointment matching placebo
  • DRUG Zovirax® cream

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2016-11-29
Est. Completion 2017-10-16
Phase Phase 2
AiCuris Anti-infective Cures

6 total trials

What the finished NCT02871492 record still lists

NCT02871492 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (172% higher).

The record links to 0 conditions, and to 3 interventions - of which Pritelivir 5% w/w ointment is the first listed.

NCT02871492 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02871492 about?

NCT02871492 is a clinical study titled "Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes". 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 star...

What is the current status of trial NCT02871492?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 362 participants. The study started on 2016-11-29. Estimated completion is 2017-10-16.

What interventions are being tested in trial NCT02871492?

The interventions under investigation include: Pritelivir 5% w/w ointment (DRUG), Pritelivir ointment matching placebo (DRUG), Zovirax® cream (DRUG).

Who is sponsoring clinical trial NCT02871492?

This trial is sponsored by AiCuris Anti-infective Cures, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02871492's enrollment target sits among peer trials

362 122nd of 2000 higher than 1,878 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02871492, the US trial registry maintained by the National Library of Medicine. NCT02871492 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.