Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Intervention: Pritelivir 5% w/w ointment; Pritelivir ointment matching placebo; Zovirax® cream
Intervention MeSH terms: Acyclovir; Pritelivir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 362.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSV, pritelivir, herpes, herpes labialis, topical,

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.
    

Eligibility criteria:

        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.