Phase 3 Clinical Study for the Treatment of Cold Sore (LIP)

Valerio Therapeutics

Status and phase

Completed

Phase 3

Conditions

Herpes Labialis

Treatments

Drug: Placebo

Drug: Acyclovir Lauriad

Study type

Interventional

Funder types

Industry

Identifiers

NCT00769314

BA2005/21/02

Details and patient eligibility

About

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.

Enrollment

1,727 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.