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

NCT ID: NCT03977792

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-07-31

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:

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

Conditions

Recurrent Herpes Labialis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental treatment

Subjects treated with BOR15001L7.

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

Group Type: EXPERIMENTAL

BOR15001L7

Intervention Type: DRUG

BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.

Comparator treatment

Subjects treated with Docosanol 10%.

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

Group Type: ACTIVE_COMPARATOR

Docosanol Cream 10%

Intervention Type: DRUG

Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.

Interventions

BOR15001L7

BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.

Intervention Type: DRUG

Docosanol Cream 10%

Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecogene 21

OTHER

Sponsor Role: collaborator

Laboratoire Boreaderme Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Etienne Khoury, PhD, CCRP

Role: CONTACT

etienne.khoury@ecogene21.org

(418) 545-1252 ext. 239

Diane Brisson, PhD, CCRP

Role: CONTACT

diane.brisson@ecogene21.org

(418) 545-1252 ext. 226

References

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.

Reference Type: BACKGROUND

PMID: 28228101 (View on PubMed)

Other Identifiers

BOR-15001L7-P2

Identifier Type: -

Identifier Source: org_study_id