Back to resultsPhase 3 Clinical Study for the Treatment of Cold Sore (LIP)
Primary Purpose
Herpes Labialis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acyclovir Lauriad
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis
Eligibility Criteria
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.
Sites / Locations
- Radiant Research, Inc.,
- Radiant Research, Inc.,
- Dermatology Private Practice
- Front Range Clinical Research
- St. Luke's Family Health,
- Clinvest, a Division of Banyan Group, Inc.,
- Rochester Clinical Research, Inc.,
- Stony Brook University Medical Center
- Center for Clinical Studies
- Center for Clinical Studies, Ltd., LLP.
- Taylor Square Private Clinic
- Central Brunswick Medical Centre
- General Teaching Hospital, Dep. Of Dermatology
- U zastavky 16
- Central military hospital Dept. of Dermatology
- University Hospital Bulovka 3rd Clinic of Inf. Diseases
- University Hospital Bulovka Dept. of Dermatology
- Hôpital St Jacques Service de Dermatologie
- Private Practice
- Hopital Fournier, Service de dermatologie
- Private Practice
- Hôpital L'Archet 2, Service de Dermatologie
- Private Practice
- Hôpital Tenon, Dermatology department
- Hôpital Saint Louis Paris, Service de Dermatologie 1
- Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
- Hôpital Nord, Service de dermatologie
- Hôpital TROUSSEAU
- Praxis Dres. Dörzapf und Partner
- Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
- Praxis
- Polikum Friedenau
- Gemeinschaftspraxis
- Laserclinic Drs. Steinert
- Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
- Praxis
- Raiffeisenstr. 15b
- Ludwig-Erhard-Platz 9-11
- Katedra i Klinika Dermatologii Collegium Medicum
- Centrum Medyczne Diabet
- Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
- Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
- NZOZ Atopia, Al. J.
- Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
- Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
- Gabinet Internistyczny
- NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
- Specjalistyczne Gabinety Lekarskie Dermed
- Cossington House Surgery
- School of Dentistry, Cardiff University
- Sidley Surgery
- Sea Road Surgery
- Saltash Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Acyclovir Lauriad 50mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Abortion of Primary Lesions
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)
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)
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
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
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
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
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])
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00769314
Brief Title
Phase 3 Clinical Study for the Treatment of Cold Sore
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onxeo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1727 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Acyclovir Lauriad 50mg
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acyclovir Lauriad
Intervention Description
50 mg muco-adhesive buccal tablets, single application on the gum
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mg muco-adhesive buccal tablets, single application on the gum
Primary Outcome Measure Information:
Title
Time to Healing (TTH) of Vesicular Primary Lesion
Description
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.
Time Frame
Assessed from time of treatment initiation through Day 14
Secondary Outcome Measure Information:
Title
Abortion of Primary Lesions
Description
Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.
Time Frame
Assessed from the time of treatment initiation through Day 14
Title
TTH of Non-primary Lesions (Aborted Lesions Excluded)
Description
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.
Time Frame
Assessed from the time of treatment initiation through Day 14
Title
Duration of Episode (DOE)
Description
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 Frame
Assessed from initiation of treatment to Day 14
Title
Time to Cessation of Symptoms
Description
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.
Time Frame
Assessed from time of treatment initiation through Day 14
Title
TTH of Aborted Primary Lesions
Description
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 Frame
Assessed from time of treatment initiation through Day 14
Title
Time to Recurrence of Non-aborted Lesions During 9-month Follow-up
Description
Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.
Time Frame
From time of initial healing through the 9-month follow-up
Title
Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up
Description
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.
Time Frame
From time of initial healing through the 9-month follow-up
Title
Symptom Intensity (Visual Analogue Scale [VAS])
Description
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.
Time Frame
Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
Title
Patient Satisfaction With Treatment
Description
At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).
Time Frame
Assessed on Day 14 (or within 24 hours of healing)
Title
Patient Assessment of Efficacy of the Treatment
Description
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).
Time Frame
Assessed on Day 14 (or within 24 hours of healing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Radiant Research, Inc.,
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Radiant Research, Inc.,
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Dermatology Private Practice
City
San Fransisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Front Range Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
St. Luke's Family Health,
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Clinvest, a Division of Banyan Group, Inc.,
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Rochester Clinical Research, Inc.,
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies, Ltd., LLP.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Taylor Square Private Clinic
City
Sydney
ZIP/Postal Code
Darlinghurst, NSW 2010
Country
Australia
Facility Name
Central Brunswick Medical Centre
City
Sydney
ZIP/Postal Code
QLD 4006
Country
Australia
Facility Name
General Teaching Hospital, Dep. Of Dermatology
City
Opava
ZIP/Postal Code
128 08 Praha 2
Country
Czech Republic
Facility Name
U zastavky 16
City
Opava
ZIP/Postal Code
747 00
Country
Czech Republic
Facility Name
Central military hospital Dept. of Dermatology
City
Praha
ZIP/Postal Code
169 02 Praha 6
Country
Czech Republic
Facility Name
University Hospital Bulovka 3rd Clinic of Inf. Diseases
City
Praha
ZIP/Postal Code
180 81 Praha 8
Country
Czech Republic
Facility Name
University Hospital Bulovka Dept. of Dermatology
City
Praha
ZIP/Postal Code
180 81 Praha 8
Country
Czech Republic
Facility Name
Hôpital St Jacques Service de Dermatologie
City
Besancon
ZIP/Postal Code
25030 BESANCON CEDEX
Country
France
Facility Name
Private Practice
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Hopital Fournier, Service de dermatologie
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Private Practice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital L'Archet 2, Service de Dermatologie
City
Nice
ZIP/Postal Code
06202 NICE Cedex
Country
France
Facility Name
Private Practice
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Tenon, Dermatology department
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Saint Louis Paris, Service de Dermatologie 1
City
Paris
ZIP/Postal Code
75475 PARIS Cedex 10
Country
France
Facility Name
Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
City
Paris
ZIP/Postal Code
75651 Paris Cedex 13
Country
France
Facility Name
Hôpital Nord, Service de dermatologie
City
St. Etienne
ZIP/Postal Code
42065 St ETIENNE Cedex 2
Country
France
Facility Name
Hôpital TROUSSEAU
City
Tours
ZIP/Postal Code
37044 TOURS Cedex
Country
France
Facility Name
Praxis Dres. Dörzapf und Partner
City
Augsburg
ZIP/Postal Code
86153
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Polikum Friedenau
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Berlin
ZIP/Postal Code
12353
Country
Germany
Facility Name
Laserclinic Drs. Steinert
City
Biberach
ZIP/Postal Code
88400
Country
Germany
Facility Name
Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Praxis
City
Frankfurt
ZIP/Postal Code
60326
Country
Germany
Facility Name
Raiffeisenstr. 15b
City
Oberkirch
ZIP/Postal Code
77704
Country
Germany
Facility Name
Ludwig-Erhard-Platz 9-11
City
Rodgau-Dudenhofen
Country
Germany
Facility Name
Katedra i Klinika Dermatologii Collegium Medicum
City
Bydgoszcz
ZIP/Postal Code
85-096
Country
Poland
Facility Name
Centrum Medyczne Diabet
City
Chrzanów
ZIP/Postal Code
32-500
Country
Poland
Facility Name
Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
NZOZ Atopia, Al. J.
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
City
Płock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Gabinet Internistyczny
City
Warszawa
ZIP/Postal Code
03-003
Country
Poland
Facility Name
NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
City
Wrocław
ZIP/Postal Code
50-354
Country
Poland
Facility Name
Specjalistyczne Gabinety Lekarskie Dermed
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Cossington House Surgery
City
Canterbury
ZIP/Postal Code
CT1 3HX
Country
United Kingdom
Facility Name
School of Dentistry, Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Sidley Surgery
City
East Sussex
ZIP/Postal Code
TN39 5HE
Country
United Kingdom
Facility Name
Sea Road Surgery
City
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Saltash Health Centre
City
Saltash
ZIP/Postal Code
PL12 6DL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Clinical Study for the Treatment of Cold Sore
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