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.
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.
Olivier Chosidow, Professor, Phone: 0033 156 01 76 70/72, Email: olivier.chosidow@tnn.aphp.fr
Central Brunswick Medical Centre, Sydney QLD 4006, Australia; Recruiting
Fiona Bisshop, Dr, Principal Investigator
Holdsworth House Medical Practice, Sydney Darlinghurst, NSW 2010, Australia; Recruiting
Mark Bloch, Dr, Principal Investigator
Taylor Square Private Clinic, Sydney Darlinghurst, NSW 2010, Australia; Recruiting
Neil Bodsworth, Dr, Principal Investigator
University Hospital Bulovka 3rd Clinic of Inf. Diseases, Praha 180 81 Praha 8, Czech Republic; Recruiting
Viktor Aster, Dr, Principal Investigator
Central military hospital Dept. of Dermatology, Praha 169 02 Praha 6, Czech Republic; Recruiting
Jana Asterova, Dr, Principal Investigator
University Hospital Bulovka Dept. of Dermatology, Praha 180 81 Praha 8, Czech Republic; Recruiting
Jana Hercogova, Professor, Principal Investigator
U zastavky 16, Opava 747 00, Czech Republic; Recruiting
Radomira Klimesova, Dr, Principal Investigator
General Teaching Hospital, Dep. Of Dermatology, Opava 128 08 Praha 2, Czech Republic; Recruiting
Ivana Krajsova, Dr, Principal Investigator
Hôpital Tenon, Dermatology department, Paris 75020, France; Recruiting
Olivier Chosidow, Prof, Principal Investigator
Private Practice, Martigues 13500, France; Recruiting
Mireille Ruer Mulard, Dr, Principal Investigator
Hôpital Saint Louis Paris, Service de Dermatologie 1, Paris 75475 PARIS Cedex 10, France; Recruiting
Louis Dubertret, Prof, Principal Investigator
Hôpital Nord, Service de dermatologie, St. Etienne 42065 St ETIENNE Cedex 2, France; Recruiting
Frédéric Cambazard, Dr, Principal Investigator
Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière, Paris 75651 Paris Cedex 13, France; Recruiting
Lofti Ben slama, Dr, Principal Investigator
Private Practice, Paris 75005, France; Recruiting
Bruno Halioua, Dr, Principal Investigator
Hôpital L'Archet 2, Service de Dermatologie, Nice 06202 NICE Cedex, France; Recruiting
Ortonne, Prof, Principal Investigator
Private Practice, Nice 06000, France; Recruiting
Gilles Rostain, Dr, Principal Investigator
Hôpital St Jacques Service de Dermatologie, Besancon 25030 BESANCON CEDEX, France; Recruiting
Philippe Humbert, Prof, Principal Investigator
Hôpital TROUSSEAU, Tours 37044 TOURS Cedex, France; Recruiting
Loïc Vaillant, Prof, Principal Investigator
Hopital Fournier, Service de dermatologie, Nancy 54000, France; Recruiting
Florence Granel, Dr, Principal Investigator
Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn, Bonn 53105, Germany; Recruiting
Thomas Bieber, Prof, Principal Investigator
Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie, Berlin 10117, Germany; Recruiting
Eggert Stockfleth, Prof, Principal Investigator
Gemeinschaftspraxis, Berlin 12353, Germany; Recruiting
Joerg Weihe, Dr, Principal Investigator
Praxis, Berlin 10789, Germany; Recruiting
Uwe Wunderlich, Dr, Principal Investigator
Praxis Dres. Dörzapf und Partner, Augsburg 86153, Germany; Recruiting
Oliver Dörzapf, Dr, Principal Investigator
Polikum Friedenau, Berlin 12157, Germany; Recruiting
Anya Miller, Dr, Principal Investigator
Laserclinic Drs. Steinert, Biberach 88400, Germany; Recruiting
Markus Steinert, Dr, Principal Investigator
Praxis, Frankfurt 60326, Germany; Recruiting
Gebhard von Hake, Dr, Principal Investigator
Ludwig-Erhard-Platz 9-11, Rodgau-Dudenhofen, Germany; Recruiting
Ingomar Naudts, Dr, Principal Investigator
Raiffeisenstr. 15b, Oberkirch 77704, Germany; Recruiting
Andreas Degen, Dr, Principal Investigator
Katedra i Klinika Dermatologii Collegium Medicum, Bydgoszcz 85-096, Poland; Recruiting
Waldemar Placek, Prof, Principal Investigator
Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii, Gdynia 81-366, Poland; Recruiting
Waldemar Placek, Prof, Principal Investigator
Specjalistyczne Gabinety Lekarskie Dermed, Łódź 90-265, Poland; Recruiting
Andrzej Kaszuba, Prof, Principal Investigator
Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska, Grudziądz 86-300, Poland; Recruiting
Elżbieta Pawlaczyk-Strugała, Dr, Principal Investigator
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną, Toruń 87-100, Poland; Recruiting
Sławomir Jeka, Dr, Principal Investigator
NZOZ Atopia, Al. J., Kraków 31-159, Poland; Recruiting
Grażyna Jasieniak - Pinis, Dr, Principal Investigator
NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz, Wrocław 50-354, Poland; Recruiting
Maciej Kozina, Dr, Principal Investigator
Gabinet Internistyczny, Warszawa 03-003, Poland; Recruiting
Robert Petryka, Dr, Principal Investigator
Centrum Medyczne Diabet, Chrzanów 32-500, Poland; Recruiting
Leszek Romanowski, Dr, Principal Investigator
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard, Płock 09-402, Poland; Recruiting
Maciej Strawczyński, Dr, Principal Investigator
School of Dentistry, Cardiff University, Cardiff CF14 4XN, United Kingdom; Recruiting
Michael Lewis, Prof, Principal Investigator
Sidley Surgery, East Sussex TN39 5HE, United Kingdom; Recruiting
Christopher Dixon, Dr, Principal Investigator
Sea Road Surgery, East Sussex TN40 1JJ, United Kingdom; Recruiting
Raj Sharma, Dr, Principal Investigator
Cossington House Surgery, Canterbury CT1 3HX, United Kingdom; Recruiting
Julian Thompson, Dr, Principal Investigator
Saltash Health Centre, Saltash PL12 6DL, United Kingdom; Recruiting
Rob Cook, Dr, Principal Investigator
Radiant Research, Inc.,, Tucson, Arizona 85710, United States; Recruiting
Frank Dunlap, Dr, Principal Investigator
Radiant Research, Inc.,, Scottsdale, Arizona 85251, United States; Recruiting
McCarty F.Timm, Dr, Principal Investigator
Dermatology Private Practice, San Fransisco, California 94114, United States; Recruiting
Marcus Conant, Dr, Principal Investigator
Front Range Clinical Research, Wheat Ridge, Colorado 80033, United States; Recruiting
Maurice Archuleta, Dr, Principal Investigator
St. Luke's Family Health,, Meridian, Idaho 83642, United States; Recruiting
William Crump, Dr, Principal Investigator
Clinvest, a Division of Banyan Group, Inc.,, Springfield, Missouri 65807, United States; Recruiting
Roger Cady, Dr, Principal Investigator
Stony Brook University Medical Center, Stony Brook, New York 11794-8091, United States; Recruiting
David Baker, Dr, Principal Investigator
Rochester Clinical Research, Inc.,, Rochester, New York 14609, United States; Recruiting
Matthew Davis, Dr, Principal Investigator
Center for Clinical Studies, Houston, Texas 77030, United States; Recruiting
Stephen Tyring, Dr, Principal Investigator
Center for Clinical Studies, Ltd., LLP., Houston, Texas 77058, United States; Recruiting
Patricia Lee, Dr, Principal Investigator
