Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes (LipP1)

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

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.

Study Overview

• Status: Completed
• Conditions: Herpes Labialis
• Intervention / Treatment: Drug: Pritelivir 5% w/w ointment; Drug: Pritelivir ointment matching placebo; Drug: Zovirax® cream

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
  • California
    • Santa Rosa, California, United States, 95405
  • Florida
    • Pinellas Park, Florida, United States, 33781
  • Minnesota
    • Edina, Minnesota, United States, 55435
  • Missouri
    • Saint Louis, Missouri, United States, 63141
  • Ohio
    • Akron, Ohio, United States, 44311
    • Cincinnati, Ohio, United States, 45236
  • South Carolina
    • Anderson, South Carolina, United States, 29621
    • Greer, South Carolina, United States, 29650
  • Texas
    • San Antonio, Texas, United States, 78229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy men and women of any ethnic group aged ≥18 years ;
• Subjects should have experienced ≥4 recurrences of herpes labialis in the previous 12-months period;
• Subjects should have experienced prodromal symptoms in at least 50% of recurrent Herpes labialis (rHL) episodes and should have developed ulcerative lesions that have progressed through vesicle, ulcer, and crust stages in at least 50% of the episodes;
• Willingness not to use any topical application (such as cosmetics, lip balm, sunscreens etc…) other than the trial medication in the area of lesion development from start of prodromal symptoms to complete healing;
• Willingness not to use any systemic and topical anti-Herpes Simplex Virus (HSV) agent during the trial participation including prescription and over-the-counter (OTC) products;
• Willingness not to use any systemic, anti-inflammatory or analgesic agents from start of prodromal symptoms to healing;
• Willingness to refrain from mechanical disruption (ie, scrubbing, lancing, shaving) of the prodromal area or lesion after start of treatment with trial medication until end of the trial participation;
• Women of child bearing potential and males must use adequate contraception;
• Subject must give written informed consent.
• Subjects with current lesion may be enrolled, but they must not treat the lesion present at screening/randomization with the trial medication; they should be instructed to wait for their next subsequent lesion

Exclusion Criteria:

• Known intolerance to pritelivir or any of the ointment ingredients;
• Known intolerance to Zovirax® Cream or any of the ingredients (ie, acyclovir, cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, and white petrolatum) or valacyclovir;
• Any skin conditions that could interfere with the assessment of herpes labialis recurrences (eg, eczema, psoriasis, acne etc…)
• Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial
• Pregnant and/or breastfeeding women
• Participation in any investigational drug trial within the last 30 days before randomization for this clinical trial
• Previous treatment with pritelivir tablets
• Previous participation in a HSV vaccination Trial unless having received placebo.
• Clinically relevant ECG abnormalities (eg, QTc according to Fridericia: QTcF > 450 ms for males and QTcF > 470 ms for females; PR > 220 ms) at screening.
• Clinically relevant abnormalities in laboratory indices at screening which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
• Known chronic infections which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
• Evidence of active malignancy or immunodeficiency disease, or require chronic use of immunosuppressive drugs (eg, systemic steroids) or topical steroids, or chronically use antiviral medication with activity against HSV.
• HIV positive based on screening labs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pritelivir 5% w/w ointment; Topical treatment (20 applications), 5 times daily for 4 days	Drug: Pritelivir 5% w/w ointment
Placebo Comparator: Pritelivir ointment matching placebo; Topical treatment (20 applications), 5 times daily for 4 days	Drug: Pritelivir ointment matching placebo
Active Comparator: Zovirax® cream; Topical treatment (20 applications), 5 times daily for 4 days	Drug: Zovirax® cream

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AiCuris Anti-infective Cures AG
• Collaborators: Novella Clinical

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: HSV, pritelivir, herpes, herpes labialis, topical,
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Acyclovir; Pritelivir
• Other Study ID Numbers: AIC316-02-II-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No