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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00769314
Other study ID # BA2005/21/02
Secondary ID
Status Completed
Phase Phase 3
First received October 8, 2008
Last updated November 21, 2012
Start date May 2007
Est. completion date August 2009

Study information

Verified date November 2012
Source Onxeo
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1727
Est. completion date August 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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, 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Australia Central Brunswick Medical Centre Sydney
Australia Taylor Square Private Clinic Sydney
Czech Republic General Teaching Hospital, Dep. Of Dermatology Opava
Czech Republic U zastavky 16 Opava
Czech Republic Central military hospital Dept. of Dermatology Praha
Czech Republic University Hospital Bulovka 3rd Clinic of Inf. Diseases Praha
Czech Republic University Hospital Bulovka Dept. of Dermatology Praha
France Hôpital St Jacques Service de Dermatologie Besancon
France Private Practice Martigues
France Hopital Fournier, Service de dermatologie Nancy
France Hôpital L'Archet 2, Service de Dermatologie Nice
France Private Practice Nice
France Hôpital Saint Louis Paris, Service de Dermatologie 1 Paris
France Hôpital Tenon, Dermatology department Paris
France Private Practice Paris
France Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière Paris
France Hôpital Nord, Service de dermatologie St. Etienne
France Hôpital TROUSSEAU Tours
Germany Praxis Dres. Dörzapf und Partner Augsburg
Germany Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie Berlin
Germany Gemeinschaftspraxis Berlin
Germany Polikum Friedenau Berlin
Germany Praxis 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
Poland Katedra i Klinika Dermatologii Collegium Medicum Bydgoszcz
Poland Centrum Medyczne Diabet Chrzanów
Poland Naukowo-Badawczy i Naukowo-Dydaktyczny Osrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii Gdynia
Poland Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska Grudziadz
Poland NZOZ Atopia, Al. J. Kraków
Poland Specjalistyczne Gabinety Lekarskie Dermed Lódz
Poland Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard Plock
Poland Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna Torun
Poland Gabinet Internistyczny Warszawa
Poland NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz Wroclaw
United Kingdom Cossington House Surgery Canterbury
United Kingdom School of Dentistry, Cardiff University Cardiff
United Kingdom Sea Road Surgery East Sussex
United Kingdom Sidley Surgery East Sussex
United Kingdom Saltash Health Centre Saltash
United States Center for Clinical Studies Houston Texas
United States Center for Clinical Studies, Ltd., LLP. Houston Texas
United States St. Luke's Family Health, Meridian Idaho
United States Rochester Clinical Research, Inc., Rochester New York
United States Dermatology Private Practice San Fransisco California
United States Radiant Research, Inc., Scottsdale Arizona
United States Clinvest, a Division of Banyan Group, Inc., Springfield Missouri
United States Stony Brook University Medical Center Stony Brook New York
United States Radiant Research, Inc., Tucson Arizona
United States Front Range Clinical Research Wheat Ridge Colorado

Sponsors (1)

Lead Sponsor Collaborator
Onxeo

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Abortion of Primary Lesions Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage. Assessed from the time of treatment initiation through Day 14 No
Secondary TTH of Non-primary Lesions (Aborted Lesions Excluded) TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator. Assessed from the time of treatment initiation through Day 14 No
Secondary Duration of Episode (DOE) For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last. Assessed from initiation of treatment to Day 14 No
Secondary Time to Cessation of Symptoms Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator. Assessed from time of treatment initiation through Day 14 No
Secondary TTH of Aborted Primary Lesions TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator. Assessed from time of treatment initiation through Day 14 No
Secondary Time to Recurrence of Non-aborted Lesions During 9-month Follow-up Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions. From time of initial healing through the 9-month follow-up No
Secondary Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period. From time of initial healing through the 9-month follow-up No
Secondary Symptom Intensity (Visual Analogue Scale [VAS]) Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from "0" was measured in millimeters (0 - 100) and recorded. Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) No
Secondary Patient Satisfaction With Treatment At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no). Assessed on Day 14 (or within 24 hours of healing) No
Secondary Patient Assessment of Efficacy of the Treatment At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active). Assessed on Day 14 (or within 24 hours of healing) No
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