Clinical trial NCT00769314: Phase 3 Clinical Study for the Treatment of Cold Sore
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Labialis
Lead sponsor: Valerio Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 1727
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Time to Healing (TTH) of Vesicular Primary Lesion
timeFrame: Assessed from time of treatment initiation through Day 14
Secondary outcomes:
measure: Abortion of Primary Lesions
timeFrame: Assessed from the time of treatment initiation through Day 14
measure: TTH of Non-primary Lesions (Aborted Lesions Excluded)
timeFrame: Assessed from the time of treatment initiation through Day 14
measure: Duration of Episode (DOE)
timeFrame: Assessed from initiation of treatment to Day 14
measure: Time to Cessation of Symptoms
timeFrame: Assessed from time of treatment initiation through Day 14
measure: TTH of Aborted Primary Lesions
timeFrame: Assessed from time of treatment initiation through Day 14
measure: Time to Recurrence of Non-aborted Lesions During 9-month Follow-up
timeFrame: From time of initial healing through the 9-month follow-up
measure: Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up
timeFrame: From time of initial healing through the 9-month follow-up
measure: Symptom Intensity (Visual Analogue Scale [VAS])
timeFrame: Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
measure: Patient Satisfaction With Treatment
timeFrame: Assessed on Day 14 (or within 24 hours of healing)
measure: Patient Assessment of Efficacy of the Treatment
timeFrame: Assessed on Day 14 (or within 24 hours of healing)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Radiant Research, Inc.,
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.,
state: Arizona
city: San Fransisco
country: United States
facility: Dermatology Private Practice
state: California
city: Wheat Ridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Meridian
country: United States
facility: St. Luke's Family Health,
state: Idaho
city: Springfield
country: United States
facility: Clinvest, a Division of Banyan Group, Inc.,
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.,
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, Ltd., LLP.
state: Texas
city: Sydney
country: Australia
facility: Taylor Square Private Clinic
city: Sydney
country: Australia
facility: Central Brunswick Medical Centre
city: Opava
country: Czech Republic
facility: General Teaching Hospital, Dep. Of Dermatology
city: Opava
country: Czech Republic
facility: U zastavky 16
city: Praha
country: Czech Republic
facility: Central military hospital Dept. of Dermatology
city: Praha
country: Czech Republic
facility: University Hospital Bulovka 3rd Clinic of Inf. Diseases
city: Praha
country: Czech Republic
facility: University Hospital Bulovka Dept. of Dermatology
city: Besancon
country: France
facility: Hôpital St Jacques Service de Dermatologie
city: Martigues
country: France
facility: Private Practice
city: Nancy
country: France
facility: Hopital Fournier, Service de dermatologie
city: Nice
country: France
facility: Private Practice
city: Nice
country: France
facility: Hôpital L'Archet 2, Service de Dermatologie
city: Paris
country: France
facility: Private Practice
city: Paris
country: France
facility: Hôpital Tenon, Dermatology department
city: Paris
country: France
facility: Hôpital Saint Louis Paris, Service de Dermatologie 1
city: Paris
country: France
facility: Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
city: St. Etienne
country: France
facility: Hôpital Nord, Service de dermatologie
city: Tours
country: France
facility: Hôpital TROUSSEAU
city: Augsburg
country: Germany
facility: Praxis Dres. Dörzapf und Partner
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
city: Berlin
country: Germany
facility: Praxis
city: Berlin
country: Germany
facility: Polikum Friedenau
city: Berlin
country: Germany
facility: Gemeinschaftspraxis
city: Biberach
country: Germany
facility: Laserclinic Drs. Steinert
city: Bonn
country: Germany
facility: Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
city: Frankfurt
country: Germany
facility: Praxis
city: Oberkirch
country: Germany
facility: Raiffeisenstr. 15b
city: Rodgau-Dudenhofen
country: Germany
facility: Ludwig-Erhard-Platz 9-11
city: Bydgoszcz
country: Poland
facility: Katedra i Klinika Dermatologii Collegium Medicum
city: Chrzanów
country: Poland
facility: Centrum Medyczne Diabet
city: Gdynia
country: Poland
facility: Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
city: Grudziądz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
city: Kraków
country: Poland
facility: NZOZ Atopia, Al. J.
city: Płock
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
city: Toruń
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
city: Warszawa
country: Poland
facility: Gabinet Internistyczny
city: Wrocław
country: Poland
facility: NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
city: Łódź
country: Poland
facility: Specjalistyczne Gabinety Lekarskie Dermed
city: Canterbury
country: United Kingdom
facility: Cossington House Surgery
city: Cardiff
country: United Kingdom
facility: School of Dentistry, Cardiff University
city: East Sussex
country: United Kingdom
facility: Sidley Surgery
city: East Sussex
country: United Kingdom
facility: Sea Road Surgery
city: Saltash
country: United Kingdom
facility: Saltash Health Centre
Study officials:
References: