Phase 3 Clinical Study for the Treatment of Cold Sore

Herpes Labialis Clinical Trial

— LIP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769314
• Other study ID #: BA2005/21/02
• 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

• Herpes Labialis

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