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Phase 3 Clinical Study for the Treatment of Cold Sore

Information source: BioAlliance Pharma SA
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

Intervention: Acyclovir Lauriad (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: BioAlliance Pharma SA

Overall contact:
Olivier Chosidow, Professor, Phone: 0033 156 01 76 70/72, Email: olivier.chosidow@tnn.aphp.fr

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.

Clinical Details

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to healing of primary vesicular lesion

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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, psoriasisÔÇŽ)

- 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 candidiasisÔÇŽ

- 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.

Locations and Contacts

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

H├┤pital Tenon, Dermatology department, Paris 75020, France; Recruiting
Olivier Chosidow, Prof, Principal Investigator

Private Practice, Martigues 13500, France; Recruiting
Mireille Ruer Mulard, Dr, Principal Investigator

H├┤pital Saint Louis Paris, Service de Dermatologie 1, Paris 75475 PARIS Cedex 10, France; Recruiting
Louis Dubertret, Prof, Principal Investigator

H├┤pital Nord, Service de dermatologie, St. Etienne 42065 St ETIENNE Cedex 2, France; Recruiting
Fr├ęd├ęric Cambazard, Dr, Principal Investigator

Service de Stomatologie et chirurgie Maxilo-Faciale.H├┤pital de la piti├ę Salp├ętri├Ęre, Paris 75651 Paris Cedex 13, France; Recruiting
Lofti Ben slama, Dr, Principal Investigator

Private Practice, Paris 75005, France; Recruiting
Bruno Halioua, Dr, Principal Investigator

H├┤pital 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

H├┤pital St Jacques Service de Dermatologie, Besancon 25030 BESANCON CEDEX, France; Recruiting
Philippe Humbert, Prof, Principal Investigator

H├┤pital 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 f├╝r Dermatologie des Universit├Ątsklinikums Bonn, Bonn 53105, Germany; Recruiting
Thomas Bieber, Prof, Principal Investigator

Charit├ę Universit├Ątsmedizin Berlin Klinik f├╝r 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. D├Ârzapf und Partner, Augsburg 86153, Germany; Recruiting
Oliver D├Ârzapf, 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 O┼Ťrodek 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, Grudzi─ůdz 86-300, Poland; Recruiting
Elżbieta Pawlaczyk-Strugała, Dr, Principal Investigator

Niepubliczny Zak┼éad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodni─ů Specjalistyczn─ů, Toru┼ä 87-100, Poland; Recruiting
Sławomir Jeka, Dr, Principal Investigator

NZOZ Atopia, Al. J., Krak├│w 31-159, Poland; Recruiting
Gra┼╝yna 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, Chrzan├│w 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

Additional Information

Starting date: May 2007
Ending date: December 2008
Last updated: October 8, 2008

Page last updated: February 12, 2009

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