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An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis

Primary Purpose

Recurrent Herpes Labialis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BOR15001L7
Docosanol Cream 10%
Sponsored by
Laboratoire Boreaderme Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Herpes Labialis focused on measuring Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provide signed informed consent and willing to comply with study-related procedures;
  • Males and females ≥18 years of age at screening;
  • Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
  • Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
  • Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.

Exclusion Criteria:

  • Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
  • Patients with herpes labialis occurring within 14 days prior to screening;
  • Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
  • Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
  • Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental treatment

    Comparator treatment

    Arm Description

    Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.

    Subjects treated with Docosanol 10%. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.

    Outcomes

    Primary Outcome Measures

    The mean change of healing time

    Secondary Outcome Measures

    The change in lesion rates following the prodromal stage
    The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions
    The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
    The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
    The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
    The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
    Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]

    Full Information

    First Posted
    May 29, 2019
    Last Updated
    September 4, 2020
    Sponsor
    Laboratoire Boreaderme Inc.
    Collaborators
    Ecogene 21
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03977792
    Brief Title
    An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
    Official Title
    A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratoire Boreaderme Inc.
    Collaborators
    Ecogene 21

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
    Detailed Description
    Secondary objectives are to: Evaluate the efficacy of BOR1500L7 on: The reduction of ulcerative lesions rates following the prodromal stage; The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage; The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages; The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages; The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis; Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Herpes Labialis
    Keywords
    Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    164 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental treatment
    Arm Type
    Experimental
    Arm Description
    Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.
    Arm Title
    Comparator treatment
    Arm Type
    Active Comparator
    Arm Description
    Subjects treated with Docosanol 10%. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.
    Intervention Type
    Drug
    Intervention Name(s)
    BOR15001L7
    Intervention Description
    BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
    Intervention Type
    Drug
    Intervention Name(s)
    Docosanol Cream 10%
    Intervention Description
    Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
    Primary Outcome Measure Information:
    Title
    The mean change of healing time
    Time Frame
    Day 1 to 12
    Secondary Outcome Measure Information:
    Title
    The change in lesion rates following the prodromal stage
    Time Frame
    Day 1 to 12
    Title
    The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions
    Time Frame
    Day 1 to 12
    Title
    The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
    Time Frame
    Day 1 to 12
    Title
    The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
    Time Frame
    Day 1 to 12
    Title
    The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
    Time Frame
    Day 1 to 12
    Title
    The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
    Time Frame
    Day 1 to 12
    Title
    Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]
    Time Frame
    Day 1 to 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide signed informed consent and willing to comply with study-related procedures; Males and females ≥18 years of age at screening; Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year; Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed); Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region. Exclusion Criteria: Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.); Patients with herpes labialis occurring within 14 days prior to screening; Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions; Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer. Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Etienne Khoury, PhD, CCRP
    Phone
    (418) 545-1252
    Ext
    239
    Email
    etienne.khoury@ecogene21.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diane Brisson, PhD, CCRP
    Phone
    (418) 545-1252
    Ext
    226
    Email
    diane.brisson@ecogene21.org

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28228101
    Citation
    Lavoie S, Cote I, Pichette A, Gauthier C, Ouellet M, Nagau-Lavoie F, Mshvildadze V, Legault J. Chemical composition and anti-herpes simplex virus type 1 (HSV-1) activity of extracts from Cornus canadensis. BMC Complement Altern Med. 2017 Feb 22;17(1):123. doi: 10.1186/s12906-017-1618-2.
    Results Reference
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    An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis

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