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Phase 3 Clinical Study for the Treatment of Cold Sore

Information source: Onxeo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Labialis

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

Phase: Phase 3

Status: Completed

Sponsored by: Onxeo

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Healing (TTH) of Vesicular Primary Lesion

Secondary outcome:

Abortion of Primary Lesions

TTH of Non-primary Lesions (Aborted Lesions Excluded)

Duration of Episode (DOE)

Time to Cessation of Symptoms

TTH of Aborted Primary Lesions

Time to Recurrence of Non-aborted Lesions During 9-month Follow-up

Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up

Symptom Intensity (Visual Analogue Scale [VAS])

Patient Satisfaction With Treatment

Patient Assessment of Efficacy of the Treatment

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 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, psoriasisÔÇŽ)

- 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 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

Central Brunswick Medical Centre, Sydney QLD 4006, Australia

Taylor Square Private Clinic, Sydney Darlinghurst, NSW 2010, Australia

General Teaching Hospital, Dep. Of Dermatology, Opava 128 08 Praha 2, Czech Republic

U zastavky 16, Opava 747 00, Czech Republic

Central military hospital Dept. of Dermatology, Praha 169 02 Praha 6, Czech Republic

University Hospital Bulovka 3rd Clinic of Inf. Diseases, Praha 180 81 Praha 8, Czech Republic

University Hospital Bulovka Dept. of Dermatology, Praha 180 81 Praha 8, Czech Republic

H├┤pital St Jacques Service de Dermatologie, Besancon 25030 BESANCON CEDEX, France

Private Practice, Martigues 13500, France

Hopital Fournier, Service de dermatologie, Nancy 54000, France

H├┤pital L'Archet 2, Service de Dermatologie, Nice 06202 NICE Cedex, France

Private Practice, Nice 06000, France

H├┤pital Saint Louis Paris, Service de Dermatologie 1, Paris 75475 PARIS Cedex 10, France

H├┤pital Tenon, Dermatology department, Paris 75020, France

Private Practice, Paris 75005, France

Service de Stomatologie et chirurgie Maxilo-Faciale.H├┤pital de la piti├ę Salp├ętri├Ęre, Paris 75651 Paris Cedex 13, France

H├┤pital Nord, Service de dermatologie, St. Etienne 42065 St ETIENNE Cedex 2, France

H├┤pital TROUSSEAU, Tours 37044 TOURS Cedex, France

Praxis Dres. D├Ârzapf und Partner, Augsburg 86153, Germany

Charit├ę Universit├Ątsmedizin Berlin Klinik f├╝r Dermatologie, Venerologie und Allergologie, Berlin 10117, Germany

Gemeinschaftspraxis, Berlin 12353, Germany

Polikum Friedenau, Berlin 12157, Germany

Praxis, Berlin 10789, Germany

Laserclinic Drs. Steinert, Biberach 88400, Germany

Klinik und Poliklinik f├╝r Dermatologie des Universit├Ątsklinikums Bonn, Bonn 53105, Germany

Praxis, Frankfurt 60326, Germany

Raiffeisenstr. 15b, Oberkirch 77704, Germany

Ludwig-Erhard-Platz 9-11, Rodgau-Dudenhofen, Germany

Katedra i Klinika Dermatologii Collegium Medicum, Bydgoszcz 85-096, Poland

Centrum Medyczne Diabet, Chrzan├│w 32-500, Poland

Naukowo-Badawczy i Naukowo-Dydaktyczny O┼Ťrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii, Gdynia 81-366, Poland

Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska, Grudzi─ůdz 86-300, Poland

NZOZ Atopia, Al. J., Krak├│w 31-159, Poland

Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard, Płock 09-402, Poland

Niepubliczny Zak┼éad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodni─ů Specjalistyczn─ů, Toru┼ä 87-100, Poland

Gabinet Internistyczny, Warszawa 03-003, Poland

NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz, Wrocław 50-354, Poland

Specjalistyczne Gabinety Lekarskie Dermed, Łódź 90-265, Poland

Cossington House Surgery, Canterbury CT1 3HX, United Kingdom

School of Dentistry, Cardiff University, Cardiff CF14 4XN, United Kingdom

Sea Road Surgery, East Sussex TN40 1JJ, United Kingdom

Sidley Surgery, East Sussex TN39 5HE, United Kingdom

Saltash Health Centre, Saltash PL12 6DL, United Kingdom

Radiant Research, Inc.,, Scottsdale, Arizona 85251, United States

Radiant Research, Inc.,, Tucson, Arizona 85710, United States

Dermatology Private Practice, San Fransisco, California 94114, United States

Front Range Clinical Research, Wheat Ridge, Colorado 80033, United States

St. Luke's Family Health,, Meridian, Idaho 83642, United States

Clinvest, a Division of Banyan Group, Inc.,, Springfield, Missouri 65807, United States

Rochester Clinical Research, Inc.,, Rochester, New York 14609, United States

Stony Brook University Medical Center, Stony Brook, New York 11794-8091, United States

Center for Clinical Studies, Houston, Texas 77030, United States

Center for Clinical Studies, Ltd., LLP., Houston, Texas 77058, United States

Additional Information

Starting date: May 2007
Last updated: November 21, 2012

Page last updated: August 23, 2015

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