Phase 3 Clinical Study for the Treatment of Cold Sore (LIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT00769314
First received: October 8, 2008
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Herpes Labialis
Drug: Acyclovir Lauriad
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by BioAlliance Pharma SA:

Primary Outcome Measures:
  • Time to Healing (TTH) of Vesicular Primary Lesion [ Time Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed from the time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessed from the time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessed from initiation of treatment to Day 14 ] [ Designated as safety issue: No ]
    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 Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed from time of treatment initiation through Day 14 ] [ Designated as safety issue: No ]
    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 Frame: From time of initial healing through the 9-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: From time of initial healing through the 9-month follow-up ] [ Designated as safety issue: No ]
    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]) [ Time Frame: Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed on Day 14 (or within 24 hours of healing) ] [ Designated as safety issue: No ]
    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).


Enrollment: 1727
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Acyclovir Lauriad 50mg
Drug: Acyclovir Lauriad
50 mg muco-adhesive buccal tablets, single application on the gum
Placebo Comparator: 2 Drug: Placebo
50 mg muco-adhesive buccal tablets, single application on the gum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769314

  Show 53 Study Locations
Sponsors and Collaborators
BioAlliance Pharma SA
  More Information

No publications provided

Responsible Party: BioAlliance Pharma SA
ClinicalTrials.gov Identifier: NCT00769314     History of Changes
Other Study ID Numbers: BA2005/21/02
Study First Received: October 8, 2008
Results First Received: October 26, 2011
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014