Herpes labialis
Conditions
Interventions
Product Name: Acyclovir Lauriad
Product Code: BA021
Pharmaceutical Form: Muco-adhesive buccal tablet
INN or Proposed INN: Acyclovir
CAS Number: 59277-89-3
Current Sponsor code: BA021
Other descriptive
Sponsors
Bioalliance Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female Age > 18 years History of recurrent herpes labialis lesions where: Recurrence is defined as at least 4 episodes in the preceding 12 months Herpes labialis lesions are characterised by their localisation on the cutaneous and/or mucosal surfaces of the lips. 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 recurrent episodes Good general health (ECOG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 aphteous 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 Treatment with topical steriods in the oral area within 4 weeks prior to study drug administration 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, except for patients who have already experienced an outbreak during study participation but have not applied the treatment because they couldn’t attend visit 3 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 days Share household with another subject already enrolled in the current study Patients who do not develop herpes episodes within 6 months after their randomisation in the study will be excluded. They will be required to return the medication to the investigating site History of alcoholism or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 labial herpes;Secondary Objective: To compare the efficacy of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus placebo on: ? The evolution of prodromal symptoms to aborted lesions; ? The healing of non primary lesions; ? The duration of episode; ? The duration of symptoms; ? The healing of aborted lesions; ? The healing of intra-oral and mucosal lesions; ? The incidence of and time to recurrence during 9 months following treatment (ancillary study in selected centres) To compare the local tolerability and general safety of acyclovir Lauriad® 50mg muco-adhesive buccal tablet to those of placebo To evaluate the concentration of acyclovir in saliva (ancillary study in selected centres) and to assess its relationship with viral load in saliva and efficacy criteria; To evaluate the adhesion time of acyclovir Lauriad® (50 mg) muco-adhesive buccal tablet, the incidence of detachment and / or swallow and the number of tablets replaced. ;Primary end point(s): Time To Healing (TTH) of primary vesicular lesion. Healing is defined as the loss of crust. Erythema may be present. It will have to be assessed by the investigator. The time to healing is the time from the treatment initiation (date and hour recorded) to the healing as defined above. The primary vesicular lesion is the first developed lesion. It should be located on the lip and should not extend on more than 1cm outside the lip. Pure intra-oral lesions are not considered as primary lesion. | — |
Countries
Czech Republic, France, Germany, United Kingdom
Outcome results
None listed