Trial Outcomes & Findings for Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes (NCT NCT02871492)

Last Updated: 2021-07-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

362 participants

Primary outcome timeframe

13 days

Results posted on

2021-07-13

Participant Flow

Patients with labial HSV develop an outbreak only a few times per year. Therefore, more patients need to be enrolled to obtain the planned number of evaluable herpes labialis recurrences, as roughly 40% of subjects do not develop a recurrence. Overall, 362 subjects were enrolled and randomized. 223 started the self-initiated treatment due to an outbreak. The remaining 139 subjects did not have an outbreak and were not treated.

Participant milestones

Participant milestones
Measure	Pritelivir 5% w/w Ointment Topical treatment (20 applications), 5 times daily for 4 days Pritelivir 5% w/w ointment	Pritelivir Ointment Matching Placebo Topical treatment (20 applications), 5 times daily for 4 days Pritelivir ointment matching placebo	Zovirax® Cream Topical treatment (20 applications), 5 times daily for 4 days Zovirax® cream
Overall Study STARTED	73	73	77
Overall Study COMPLETED	67	70	71
Overall Study NOT COMPLETED	6	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Pritelivir 5% w/w Ointment Topical treatment (20 applications), 5 times daily for 4 days Pritelivir 5% w/w ointment	Pritelivir Ointment Matching Placebo Topical treatment (20 applications), 5 times daily for 4 days Pritelivir ointment matching placebo	Zovirax® Cream Topical treatment (20 applications), 5 times daily for 4 days Zovirax® cream
Overall Study Lost to Follow-up	6	3	5
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pritelivir 5% w/w Ointment n=73 Participants Topical treatment (20 applications), 5 times daily for 4 days Pritelivir 5% w/w ointment	Pritelivir Ointment Matching Placebo n=73 Participants Topical treatment (20 applications), 5 times daily for 4 days Pritelivir ointment matching placebo	Zovirax® Cream n=77 Participants Topical treatment (20 applications), 5 times daily for 4 days Zovirax® cream	Total n=223 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	49 years n=7 Participants	51 years n=5 Participants	51 years n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	53 Participants n=7 Participants	56 Participants n=5 Participants	161 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	65 Participants n=7 Participants	65 Participants n=5 Participants	193 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	73 Participants n=5 Participants	73 Participants n=7 Participants	77 Participants n=5 Participants	223 Participants n=4 Participants
BMI	27.8 kg/m^2 n=5 Participants	27.3 kg/m^2 n=7 Participants	28.1 kg/m^2 n=5 Participants	27.8 kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: 13 days

Population: Primary analysis for the ITT ( intent to treat) population; multiple imputation.

Outcome measures

Outcome measures
Measure	Pritelivir 5% w/w Ointment n=71 Participants Topical treatment (20 applications), 5 times daily for 4 days Pritelivir 5% w/w ointment	Pritelivir Ointment Matching Placebo n=72 Participants Topical treatment (20 applications), 5 times daily for 4 days Pritelivir ointment matching placebo	Zovirax® Cream n=75 Participants Topical treatment (20 applications), 5 times daily for 4 days Zovirax® cream
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment Non-ulcerative recurrences	21.8 percentage of partcipants	16.4 percentage of partcipants	19.9 percentage of partcipants
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment Ulcerative recurrences	78.2 percentage of partcipants	83.6 percentage of partcipants	80.1 percentage of partcipants

Adverse Events

Pritelivir 5% w/w Ointment

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Pritelivir Ointment Matching Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Zovirax® Cream

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Information Desk

AiCuris Anti-infective Cures GmbH

Phone: +4920231763

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results or other data of this Study without the prior written consent of Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Pritelivir 5% w/w Ointment n=73 participants at risk Topical treatment (20 applications), 5 times daily for 4 days Pritelivir 5% w/w ointment	Pritelivir Ointment Matching Placebo n=73 participants at risk Topical treatment (20 applications), 5 times daily for 4 days Pritelivir ointment matching placebo	Zovirax® Cream n=77 participants at risk Topical treatment (20 applications), 5 times daily for 4 days Zovirax® cream
Blood and lymphatic system disorders Anaemia	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Cardiac disorders Palpitations	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Ear and labyrinth disorders Ear Pain	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Abdominal discomfort	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Chapped lips	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Diarrhoea	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Lip blister	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Nausea	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Gastrointestinal disorders Toothache	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
General disorders Application site inflammation	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
General disorders Application site pain	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
General disorders Induration	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
General disorders Pain	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
General disorders Pyrexia	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Bronchitis	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Gastroenteritis	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Oral herpes	13.7% 10/73 • Number of events 10 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	6.8% 5/73 • Number of events 5 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	3.9% 3/77 • Number of events 3 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Pharyngitis streptococcal	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Pyuria	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Respiratory tract infection	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Rhinitis	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Sinusitis	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Upper respiratory tract infection	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Infections and infestations Viral upper respiratory tract infection	2.7% 2/73 • Number of events 2 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	2.7% 2/73 • Number of events 2 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	2.6% 2/77 • Number of events 2 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Muscle strain	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Injury, poisoning and procedural complications Wound complication	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Blood creatine phosphokinase increased	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	2.6% 2/77 • Number of events 2 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Blood pressure increased	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Blood sodium decreased	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations C-reactive protein increased	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Cardiac murmur	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Electrocardiogram ST-T change	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Electrocardiogram T wave inversion	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.3% 1/77 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.
Investigations Eosinophil count increased	0.00% 0/73 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	1.4% 1/73 • Number of events 1 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.	0.00% 0/77 • 10 months Subjects were interviewed by the investigational site staff pre-dose and at every visit using nonleading questions.