Herpes LabialisPhase 3LIPNCT00769314
Phase 3 Clinical Study for the Treatment of Cold Sore
A Phase 3 study testing Acyclovir Lauriad in people with Herpes Labialis, run by Valerio Therapeutics at 53 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Acyclovir Lauriad
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,727 participants
- Where
- 53 sitesin 7 countries
- Study dates
- May 2007to Aug 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
53 sites in 7 countries.
53 sites in 7 countries
France11 sites
Hôpital St Jacques Service de Dermatologie
Besançon, 25030 BESANCON CEDEX
Private Practice
Martigues, 13500
Hopital Fournier, Service de dermatologie
Nancy, 54000
Private Practice
Nice, 06000
Hôpital L'Archet 2, Service de Dermatologie
Nice, 06202 NICE Cedex
Private Practice
Paris, 75005
Hôpital Tenon, Dermatology department
Paris, 75020
Hôpital Saint Louis Paris, Service de Dermatologie 1
Paris, 75475 PARIS Cedex 10
Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière
Paris, 75651 Paris Cedex 13
Hôpital Nord, Service de dermatologie
Saint-Etienne, 42065 St ETIENNE Cedex 2
Hôpital TROUSSEAU
Tours, 37044 TOURS Cedex
United States10 sites
Center for Clinical Studies
Houston, Texas, 77030
Center for Clinical Studies, Ltd., LLP.
Houston, Texas, 77058
St. Luke's Family Health,
Meridian, Idaho, 83642
Rochester Clinical Research, Inc.,
Rochester, New York, 14609
Dermatology Private Practice
San Francisco, California, 94114
Radiant Research, Inc.,
Scottsdale, Arizona, 85251
Clinvest, a Division of Banyan Group, Inc.,
Springfield, Missouri, 65807
Stony Brook University Medical Center
Stony Brook, New York, 11794-8091
Radiant Research, Inc.,
Tucson, Arizona, 85710
Front Range Clinical Research
Wheat Ridge, Colorado, 80033
Germany10 sites
Praxis Dres. Dörzapf und Partner
Augsburg, 86153
Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie
Berlin, 10117
Praxis
Berlin, 10789
Polikum Friedenau
Berlin, 12157
Gemeinschaftspraxis
Berlin, 12353
Laserclinic Drs. Steinert
Biberach, 88400
Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn
Bonn, 53105
Praxis
Frankfurt, 60326
Raiffeisenstr. 15b
Oberkirch, 77704
Ludwig-Erhard-Platz 9-11
Rodgau-Dudenhofen
Poland10 sites
Katedra i Klinika Dermatologii Collegium Medicum
Bydgoszcz, 85-096
Centrum Medyczne Diabet
Chrzanów, 32-500
Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii
Gdynia, 81-366
Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska
Grudziądz, 86-300
NZOZ Atopia, Al. J.
Krakow, 31-159
Specjalistyczne Gabinety Lekarskie Dermed
Lodz, 90-265
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard
Płock, 09-402
Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
Torun, 87-100
Gabinet Internistyczny
Warsaw, 03-003
NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz
Wroclaw, 50-354
Czechia5 sites
General Teaching Hospital, Dep. Of Dermatology
Opava, 128 08 Praha 2
U zastavky 16
Opava, 747 00
Central military hospital Dept. of Dermatology
Prague, 169 02 Praha 6
University Hospital Bulovka 3rd Clinic of Inf. Diseases
Prague, 180 81 Praha 8
University Hospital Bulovka Dept. of Dermatology
Prague, 180 81 Praha 8
United Kingdom5 sites
Cossington House Surgery
Canterbury, CT1 3HX
School of Dentistry, Cardiff University
Cardiff, CF14 4XN
Sidley Surgery
East Sussex, TN39 5HE
Sea Road Surgery
East Sussex, TN40 1JJ
Saltash Health Centre
Saltash, PL12 6DL
Australia2 sites
Taylor Square Private Clinic
Sydney, Darlinghurst, NSW 2010
Central Brunswick Medical Centre
Sydney, QLD 4006
About this study
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.
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
- Being tested
- Acyclovir Lauriad, Placebo
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir LauriadDrug
50 mg muco-adhesive buccal tablets, single application on the gum
PlaceboDrug
50 mg muco-adhesive buccal tablets, single application on the gum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Acyclovir Lauriad 50mg Receives: Drug: Acyclovir Lauriad |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed from time of treatment initiation through Day 14
Secondary outcomes (10)
Abortion of Primary Lesions
Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.
Measured: Assessed from the time of treatment initiation through Day 14
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.
Measured: Assessed from the time of treatment initiation through Day 14
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.
Measured: Assessed from initiation of treatment to Day 14
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.
Measured: Assessed from time of treatment initiation through Day 14
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.
Measured: Assessed from time of treatment initiation through Day 14
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.
Measured: From time of initial healing through the 9-month follow-up
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.
Measured: From time of initial healing through the 9-month follow-up
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.
Measured: Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
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).
Measured: Assessed on Day 14 (or within 24 hours of healing)
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).
Measured: Assessed on Day 14 (or within 24 hours of healing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionNov 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,727 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769314
- Sponsor's protocol ID
- BA2005/21/02
- Acronym
- LIP
- Status last verified
- Nov 2012
- First submitted
- 8 Oct 2008
- Last updated
- 21 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00769314
- Acronym / sponsor ID
- LIP / BA2005/21/02
- Conditions
- Herpes Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,727 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Posted 21 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Acyclovir LauriadAcyclovir Lauriad 50mg |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of recurrent herpes labialis lesions where:
- Good general health (ECOG < 2), immunocompetent
- Signed and dated written informed consent
- Women of childbearing potential must have effective contraception method
Key exclusion criteria (21 listed)
- 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…
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir Lauriad50 mg muco-adhesive buccal tablets, single application on the gum | Drug | 1 |
| Placebo50 mg muco-adhesive buccal tablets, single application on the gum | Drug | 2 |
Primary outcome
Time to Healing (TTH) of Vesicular Primary Lesion
Time frame: 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.
10 secondary outcomes
Abortion of Primary Lesions
Time frame: Assessed from the time of treatment initiation through Day 14
TTH of Non-primary Lesions (Aborted Lesions Excluded)
Time frame: Assessed from the time of treatment initiation through Day 14
Duration of Episode (DOE)
Time frame: Assessed from initiation of treatment to Day 14
Time to Cessation of Symptoms
Time frame: Assessed from time of treatment initiation through Day 14
TTH of Aborted Primary Lesions
Time frame: Assessed from time of treatment initiation through Day 14
Time to Recurrence of Non-aborted Lesions During 9-month Follow-up
Time frame: From time of initial healing through the 9-month follow-up
Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up
Time frame: From time of initial healing through the 9-month follow-up
Symptom Intensity (Visual Analogue Scale [VAS])
Time frame: Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)
Patient Satisfaction With Treatment
Time frame: Assessed on Day 14 (or within 24 hours of healing)
Patient Assessment of Efficacy of the Treatment
Time frame: Assessed on Day 14 (or within 24 hours of healing)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir Lauriad in people with Herpes Labialis, run by Valerio Therapeutics at 53 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, United States, Germany, Poland, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Healing (TTH) of Vesicular Primary Lesion (time frame: Assessed from time of treatment initiation through Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2012.