Phase 3 Clinical Study for the Treatment of Cold Sore

Phase 3

Completed

Conditions: Herpes Labialis

Interventions: Drug: Acyclovir Lauriad
Drug: Placebo

Registration Number: NCT00769314

Lead Sponsor: Valerio Therapeutics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1727

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Acyclovir Lauriad	Acyclovir Lauriad 50mg
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to Healing (TTH) of Vesicular Primary Lesion	Assessed from time of treatment initiation through Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Abortion of Primary Lesions	Assessed from the time of treatment initiation through Day 14	Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.
TTH of Non-primary Lesions (Aborted Lesions Excluded)	Assessed from the time of treatment initiation through Day 14	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.
Duration of Episode (DOE)	Assessed from initiation of treatment to Day 14	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.
Time to Cessation of Symptoms	Assessed from time of treatment initiation through Day 14	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.
TTH of Aborted Primary Lesions	Assessed from time of treatment initiation through Day 14	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.
Time to Recurrence of Non-aborted Lesions During 9-month Follow-up	From time of initial healing through the 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.
Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up	From time of initial healing through the 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.
Symptom Intensity (Visual Analogue Scale [VAS])	Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)	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.
Patient Satisfaction With Treatment	Assessed on Day 14 (or within 24 hours of healing)	At the end of study (Day 14 \[or within 24 hours of healing\]), patients were asked whether they were satisfied with treatment (yes/no).
Patient Assessment of Efficacy of the Treatment	Assessed on Day 14 (or within 24 hours of healing)	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).

Trial Locations

Locations (49): Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
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Gdynia, Poland
Gabinet Internistyczny
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Warszawa, Poland
NZOZ Atopia, Al. J.
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Kraków, Poland
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
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Płock, Poland
Sea Road Surgery
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East Sussex, United Kingdom
Cossington House Surgery
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Canterbury, United Kingdom
Sidley Surgery
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East Sussex, United Kingdom
Saltash Health Centre
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Saltash, United Kingdom
School of Dentistry, Cardiff University
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Cardiff, United Kingdom
Specjalistyczne Gabinety Lekarskie Dermed
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Łódź, Poland
Center for Clinical Studies
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Houston, Texas, United States
Center for Clinical Studies, Ltd., LLP.
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Houston, Texas, United States
Radiant Research, Inc.,
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Tucson, Arizona, United States
Front Range Clinical Research
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Wheat Ridge, Colorado, United States
Dermatology Private Practice
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San Fransisco, California, United States
Clinvest, a Division of Banyan Group, Inc.,
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Springfield, Missouri, United States
St. Luke's Family Health,
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Meridian, Idaho, United States
Rochester Clinical Research, Inc.,
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Rochester, New York, United States
Stony Brook University Medical Center
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Stony Brook, New York, United States
General Teaching Hospital, Dep. Of Dermatology
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Opava, Czech Republic
Taylor Square Private Clinic
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Sydney, Australia
Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
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Bonn, Germany
U zastavky 16
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Opava, Czech Republic
University Hospital Bulovka 3rd Clinic of Inf. Diseases
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Praha, Czech Republic
Hopital Fournier, Service de dermatologie
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Nancy, France
Central Brunswick Medical Centre
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Sydney, Australia
Central military hospital Dept. of Dermatology
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Praha, Czech Republic
University Hospital Bulovka Dept. of Dermatology
🇨🇿
Praha, Czech Republic
Private Practice
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Paris, France
Hôpital St Jacques Service de Dermatologie
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Besancon, France
Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
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Paris, France
Hôpital L'Archet 2, Service de Dermatologie
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Nice, France
Hôpital Nord, Service de dermatologie
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St. Etienne, France
Hôpital Saint Louis Paris, Service de Dermatologie 1
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Paris, France
Praxis Dres. Dörzapf und Partner
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Augsburg, Germany
Hôpital Tenon, Dermatology department
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Paris, France
Hôpital TROUSSEAU
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Tours, France
Laserclinic Drs. Steinert
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Biberach, Germany
Gemeinschaftspraxis
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Berlin, Germany
Praxis
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Frankfurt, Germany
Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
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Berlin, Germany
Polikum Friedenau
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Berlin, Germany
Ludwig-Erhard-Platz 9-11
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Rodgau-Dudenhofen, Germany
Katedra i Klinika Dermatologii Collegium Medicum
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Bydgoszcz, Poland
Raiffeisenstr. 15b
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Oberkirch, Germany
Centrum Medyczne Diabet
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Chrzanów, Poland
Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
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Grudziądz, Poland
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
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Toruń, Poland
NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
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Wrocław, Poland