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

A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Herpes Labialis
• Intervention / Treatment: Drug: BOR15001L7; Drug: Docosanol Cream 10%

Detailed Description

Secondary objectives are to:

1. 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;
2. Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Etienne Khoury, PhD, CCRP; Phone Number: 239 (418) 545-1252; Email: etienne.khoury@ecogene21.org
• Study Contact Backup: Name: Diane Brisson, PhD, CCRP; Phone Number: 226 (418) 545-1252; Email: diane.brisson@ecogene21.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental treatment; Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.	Drug: BOR15001L7; BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
Active Comparator: Comparator treatment; Subjects treated with Docosanol 10%. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.	Drug: Docosanol Cream 10%; Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean change of healing time	Day 1 to 12

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in lesion rates following the prodromal stage	Day 1 to 12
The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions	Day 1 to 12
The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages	Day 1 to 12
The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages	Day 1 to 12
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	Day 1 to 12
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	Day 1 to 12
Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]	Day 1 to 12

Collaborators and Investigators

• Sponsor: Laboratoire Boreaderme Inc.
• Collaborators: Ecogene 21

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Herpesviridae Infections; Skin Diseases, Infectious; Herpes Simplex
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Virus Diseases; Infections; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Recurrence; Herpes Simplex; Herpes Labialis; Anti-Infective Agents; Antiviral Agents; Docosanol
• Other Study ID Numbers: BOR-15001L7-P2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No