Phase 3 Clinical Study for the Treatment of Cold Sore - Full Text View

Sponsor:	BioAlliance Pharma SA
Information provided by:	BioAlliance Pharma SA
ClinicalTrials.gov Identifier:	NCT00769314

Purpose

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.

Condition	Intervention	Phase
Herpes Labialis	Drug: Acyclovir Lauriad Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cold Sores

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by BioAlliance Pharma SA:

Primary Outcome Measures:

Time to healing of primary vesicular lesion [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	1727
Study Start Date:	May 2007
Study Completion Date:	August 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Acyclovir Lauriad 50mg	Drug: Acyclovir Lauriad 50 mg muco-adhesive buccal tablets, once a day application
Placebo Comparator: 2	Drug: Placebo 50 mg muco-adhesive buccal tablets, once a day application

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 recurrent 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 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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769314

Show 53 Study Locations

Sponsors and Collaborators

BioAlliance Pharma SA

More Information

No publications provided

Responsible Party:	BioAlliance Pharma
ClinicalTrials.gov Identifier:	NCT00769314 History of Changes
Other Study ID Numbers:	BA2005/21/02
Study First Received:	October 8, 2008
Last Updated:	April 1, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases

Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012