Trial · NCT02871492

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

NCT02871492, Phase 2, Completed, AiCuris Anti-infective Cures AG; results first posted 2021-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes. Trials, record NCT02871492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02871492

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
NCT number: NCT02871492
Status: Completed
Phases: Phase 2
Enrollment: 362 participants, actual
Lead sponsor: AiCuris Anti-infective Cures AG
Conditions: Herpes Labialis
Interventions: Pritelivir 5% w/w ointment, Pritelivir ointment matching placebo, Zovirax® cream
First posted: 2016-08-18
Last updated: 2021-07-13
Results first posted: 2021-07-13

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	13 days	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

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	13 days	Primary analysis for the ITT ( intent to treat) population; multiple imputation.	percentage of partcipants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Pritelivir 5% w/w Ointment	Non-ulcerative recurrences	21.8	percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Pritelivir Ointment Matching Placebo	Non-ulcerative recurrences	16.4	percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Zovirax® Cream	Non-ulcerative recurrences	19.9	percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Pritelivir 5% w/w Ointment	Ulcerative recurrences	78.2	percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Pritelivir Ointment Matching Placebo	Ulcerative recurrences	83.6	percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment	Zovirax® Cream	Ulcerative recurrences	80.1	percentage of partcipants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pritelivir 5% w/w Ointment	73
Overall Study	STARTED	Pritelivir Ointment Matching Placebo	73
Overall Study	STARTED	Zovirax® Cream	77
Overall Study	COMPLETED	Pritelivir 5% w/w Ointment	67
Overall Study	COMPLETED	Pritelivir Ointment Matching Placebo	70
Overall Study	COMPLETED	Zovirax® Cream	71
Overall Study	NOT COMPLETED	Pritelivir 5% w/w Ointment	6
Overall Study	NOT COMPLETED	Pritelivir Ointment Matching Placebo	3
Overall Study	NOT COMPLETED	Zovirax® Cream	6

Source ClinicalTrials.gov

Adverse events210

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Pritelivir 5% w/w Ointment	1	73	1
other	Anaemia	Blood and lymphatic system disorders	Pritelivir Ointment Matching Placebo	1	73	1
other	Anaemia	Blood and lymphatic system disorders	Zovirax® Cream	0	77	0
other	Palpitations	Cardiac disorders	Pritelivir 5% w/w Ointment	1	73	1
other	Palpitations	Cardiac disorders	Pritelivir Ointment Matching Placebo	0	73	0
other	Palpitations	Cardiac disorders	Zovirax® Cream	0	77	0
other	Ear Pain	Ear and labyrinth disorders	Pritelivir 5% w/w Ointment	1	73	1
other	Ear Pain	Ear and labyrinth disorders	Pritelivir Ointment Matching Placebo	0	73	0
other	Ear Pain	Ear and labyrinth disorders	Zovirax® Cream	0	77	0
other	Eustachian tube dysfunction	Ear and labyrinth disorders	Pritelivir 5% w/w Ointment	0	73	0

1 to 10 of 210Source ClinicalTrials.gov

See all 210 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pritelivir 5% w/w Ointment	0	73
Total, all-cause mortality	Pritelivir Ointment Matching Placebo	0	73
Total, all-cause mortality	Zovirax® Cream	0	77
Total, other adverse events	Pritelivir 5% w/w Ointment	30	73
Total, other adverse events	Pritelivir Ointment Matching Placebo	27	73
Total, other adverse events	Zovirax® Cream	27	77
Total, serious adverse events	Pritelivir 5% w/w Ointment	0	73
Total, serious adverse events	Pritelivir Ointment Matching Placebo	0	73
Total, serious adverse events	Zovirax® Cream	0	77

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02871492

GET https://conductscience.org/api/trials/v1/NCT02871492/events?page=2

API reference For AI assistants