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

Sponsor

Laboratoire Boreaderme Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT03977792

Collaborator

Ecogene 21 (Other)

164

Enrollment

Arms

21.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Herpes Labialis	Drug: BOR15001L7 Drug: Docosanol Cream 10%	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The mean change of healing time [Day 1 to 12]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.