Phase 3 Clinical Study for the Treatment of Cold Sore

NCT00769314 | Completed Phase 3 Results

• 1 other identifier: BA2005/21/02
• Study Type: interventional
• Target: 1,727
• Locations: 7 countries
• Sites: 53

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.

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

• Time to Healing (TTH) of Vesicular Primary Lesion

  Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.

  Assessed from time of treatment initiation through Day 14

Secondary Outcomes (10)

• Abortion of Primary Lesions

  Assessed from the time of treatment initiation through Day 14

• TTH of Non-primary Lesions (Aborted Lesions Excluded)

  Assessed from the time of treatment initiation through Day 14

• Duration of Episode (DOE)

  Assessed from initiation of treatment to Day 14

• Time to Cessation of Symptoms

  Assessed from time of treatment initiation through Day 14

• TTH of Aborted Primary Lesions

  Assessed from time of treatment initiation through Day 14

Study Arms (2)

1

EXPERIMENTAL

Acyclovir Lauriad 50mg

Drug: Acyclovir Lauriad

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acyclovir Lauriad DRUG

50 mg muco-adhesive buccal tablets, single application on the gum

1

Placebo DRUG

50 mg muco-adhesive buccal tablets, single application on the gum

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (53)

Radiant Research, Inc.,

Scottsdale, Arizona, 85251, United States

Location

Radiant Research, Inc.,

Tucson, Arizona, 85710, United States

Location

Dermatology Private Practice

San Francisco, California, 94114, United States

Location

Front Range Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

St. Luke's Family Health,

Meridian, Idaho, 83642, United States

Location

Clinvest, a Division of Banyan Group, Inc.,

Springfield, Missouri, 65807, United States

Location

Rochester Clinical Research, Inc.,

Rochester, New York, 14609, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8091, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Center for Clinical Studies, Ltd., LLP.

Houston, Texas, 77058, United States

Location

Taylor Square Private Clinic

Sydney, Darlinghurst, NSW 2010, Australia

Location

Central Brunswick Medical Centre

Sydney, QLD 4006, Australia

Location

General Teaching Hospital, Dep. Of Dermatology

Opava, 128 08 Praha 2, Czechia

Location

U zastavky 16

Opava, 747 00, Czechia

Location

Central military hospital Dept. of Dermatology

Prague, 169 02 Praha 6, Czechia

Location

University Hospital Bulovka 3rd Clinic of Inf. Diseases

Prague, 180 81 Praha 8, Czechia

Location

University Hospital Bulovka Dept. of Dermatology

Prague, 180 81 Praha 8, Czechia

Location

Hôpital St Jacques Service de Dermatologie

Besançon, 25030 BESANCON CEDEX, France

Location

Private Practice

Martigues, 13500, France

Location

Hopital Fournier, Service de dermatologie

Nancy, 54000, France

Location

Private Practice

Nice, 06000, France

Location

Hôpital L'Archet 2, Service de Dermatologie

Nice, 06202 NICE Cedex, France

Location

Private Practice

Paris, 75005, France

Location

Hôpital Tenon, Dermatology department

Paris, 75020, France

Location

Hôpital Saint Louis Paris, Service de Dermatologie 1

Paris, 75475 PARIS Cedex 10, France

Location

Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière

Paris, 75651 Paris Cedex 13, France

Location

Hôpital Nord, Service de dermatologie

Saint-Etienne, 42065 St ETIENNE Cedex 2, France

Location

Hôpital TROUSSEAU

Tours, 37044 TOURS Cedex, France

Location

Praxis Dres. Dörzapf und Partner

Augsburg, 86153, Germany

Location

Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie

Berlin, 10117, Germany

Location

Praxis

Berlin, 10789, Germany

Location

Polikum Friedenau

Berlin, 12157, Germany

Location

Gemeinschaftspraxis

Berlin, 12353, Germany

Location

Laserclinic Drs. Steinert

Biberach, 88400, Germany

Location

Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn

Bonn, 53105, Germany

Location

Praxis

Frankfurt, 60326, Germany

Location

Raiffeisenstr. 15b

Oberkirch, 77704, Germany

Location

Ludwig-Erhard-Platz 9-11

Rodgau-Dudenhofen, Germany

Location

Katedra i Klinika Dermatologii Collegium Medicum

Bydgoszcz, 85-096, Poland

Location

Centrum Medyczne Diabet

Chrzanów, 32-500, Poland

Location

Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii

Gdynia, 81-366, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska

Grudziądz, 86-300, Poland

Location

NZOZ Atopia, Al. J.

Krakow, 31-159, Poland

Location

Specjalistyczne Gabinety Lekarskie Dermed

Lodz, 90-265, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard

Płock, 09-402, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

Torun, 87-100, Poland

Location

Gabinet Internistyczny

Warsaw, 03-003, Poland

Location

NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz

Wroclaw, 50-354, Poland

Location

Cossington House Surgery

Canterbury, CT1 3HX, United Kingdom

Location

School of Dentistry, Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

Sidley Surgery

East Sussex, TN39 5HE, United Kingdom

Location

Sea Road Surgery

East Sussex, TN40 1JJ, United Kingdom

Location

Saltash Health Centre

Saltash, PL12 6DL, United Kingdom

Location

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Pierre ATTALI
• Organization: BioAlliance Pharma

pierre.attali@bioalliancepharma.com

+33145587600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: May 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: August 1, 2009
• Last Updated: December 21, 2012
• Results First Posted: December 21, 2012

Record last verified: 2012-11

Locations

US (10); CZ (5); FR (11); DE (10); PL (10); GB (5); AU (2)