Phase 3 Clinical Study for the Treatment of Cold Sore
Condition: Herpes Labialis
MeSH terms: Herpes Labialis
Intervention: Acyclovir Lauriad; Placebo
Intervention description: 50 mg muco-adhesive buccal tablets, single application on the gum; 50 mg muco-adhesive buccal tablets, single application on the gum
Intervention MeSH terms: Acyclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1727.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal
      tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of recurrent herpes labialis lesions where:

               -  At least 50% of previous episodes produced classical lesions to the vesicular
                  stage (i.e. episodes that progressed through macula, papule, vesicle, crust and
                  healed);

               -  Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis
                  lesions in at least 50% of the previous herpes episodes

          -  Good general health (ECOG < 2), immunocompetent

          -  Signed and dated written informed consent

          -  Women of childbearing potential must have effective contraception method

        Exclusion Criteria:

          -  More than 50% of recurrences that aborted spontaneously in the past 12 months

          -  Primary herpes lesion outside the lips (e.g. nose, chin, etc.)

          -  Abnormal peri-oral skin condition that might affect the normal course of cold sores
             (e.g. eczema, psoriasis…)

          -  Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including
             recurrent oral aphthous disease

          -  Oral diseases that might interfere with the evaluation of the efficacy or safety of
             the treatments, including gingivitis, parondotis, mucositis, oropharyngeal
             candidiasis…

          -  History of infection known to be resistant to acyclovir family agents

          -  Previous vaccination against herpes

          -  Concomitant treatment likely to interfere with acyclovir

          -  Allergy to any acyclovir containing agents

          -  Immunocompromised condition, including HIV+

          -  Unability to properly understand protocol requirements, to follow the study
             procedures, to complete the patient diary or to start the self-initiation of the
             treatment

          -  Upper full or partial dentures with acrylic border in the canine fossa

          -  Milk allergy or known history of hypersensitivity to one of the components of the
             products

          -  Rare hereditary problems of galactose intolerance.

          -  Lactase enzyme deficiency or glucose galactose malabsorption

          -  Clinically significant abnormal level of serum creatinine

          -  Patients whose occupations make them unlikely to return to the clinic within 24h of
             treatment initiation

          -  Pregnancy or breast-feeding

          -  Investigational drug or immunomodulator treatment in the 30 days prior randomisation

          -  Prior enrollment in this study

          -  Participation in another therapeutic trial evaluating new drugs or which could
             interfere with the evolution of herpes labialis or the evaluation of the drug in the
             study within preceding 30 day.