Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1727 participants
INTERVENTIONAL
2007-05-31
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Acyclovir Lauriad 50mg
Acyclovir Lauriad
50 mg muco-adhesive buccal tablets, single application on the gum
2
Placebo
50 mg muco-adhesive buccal tablets, single application on the gum
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acyclovir Lauriad
50 mg muco-adhesive buccal tablets, single application on the gum
Placebo
50 mg muco-adhesive buccal tablets, single application on the gum
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Valerio Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research, Inc.,
Scottsdale, Arizona, United States
Radiant Research, Inc.,
Tucson, Arizona, United States
Dermatology Private Practice
San Francisco, California, United States
Front Range Clinical Research
Wheat Ridge, Colorado, United States
St. Luke's Family Health,
Meridian, Idaho, United States
Clinvest, a Division of Banyan Group, Inc.,
Springfield, Missouri, United States
Rochester Clinical Research, Inc.,
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies, Ltd., LLP.
Houston, Texas, United States
Taylor Square Private Clinic
Sydney, , Australia
Central Brunswick Medical Centre
Sydney, , Australia
General Teaching Hospital, Dep. Of Dermatology
Opava, , Czechia
U zastavky 16
Opava, , Czechia
Central military hospital Dept. of Dermatology
Prague, , Czechia
University Hospital Bulovka 3rd Clinic of Inf. Diseases
Prague, , Czechia
University Hospital Bulovka Dept. of Dermatology
Prague, , Czechia
Hôpital St Jacques Service de Dermatologie
Besançon, , France
Private Practice
Martigues, , France
Hopital Fournier, Service de dermatologie
Nancy, , France
Private Practice
Nice, , France
Hôpital L'Archet 2, Service de Dermatologie
Nice, , France
Private Practice
Paris, , France
Hôpital Tenon, Dermatology department
Paris, , France
Hôpital Saint Louis Paris, Service de Dermatologie 1
Paris, , France
Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
Paris, , France
Hôpital Nord, Service de dermatologie
Saint-Etienne, , France
Hôpital TROUSSEAU
Tours, , France
Praxis Dres. Dörzapf und Partner
Augsburg, , Germany
Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
Berlin, , Germany
Praxis
Berlin, , Germany
Polikum Friedenau
Berlin, , Germany
Gemeinschaftspraxis
Berlin, , Germany
Laserclinic Drs. Steinert
Biberach, , Germany
Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
Bonn, , Germany
Praxis
Frankfurt, , Germany
Raiffeisenstr. 15b
Oberkirch, , Germany
Ludwig-Erhard-Platz 9-11
Rodgau-Dudenhofen, , Germany
Katedra i Klinika Dermatologii Collegium Medicum
Bydgoszcz, , Poland
Centrum Medyczne Diabet
Chrzanów, , Poland
Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
Gdynia, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
Grudziądz, , Poland
NZOZ Atopia, Al. J.
Krakow, , Poland
Specjalistyczne Gabinety Lekarskie Dermed
Lodz, , Poland
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
Płock, , Poland
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
Torun, , Poland
Gabinet Internistyczny
Warsaw, , Poland
NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
Wroclaw, , Poland
Cossington House Surgery
Canterbury, , United Kingdom
School of Dentistry, Cardiff University
Cardiff, , United Kingdom
Sidley Surgery
East Sussex, , United Kingdom
Sea Road Surgery
East Sussex, , United Kingdom
Saltash Health Centre
Saltash, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BA2005/21/02
Identifier Type: -
Identifier Source: org_study_id