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

Laboratoire Boreaderme

Status and phase: Unknown; Phase 2

Conditions: Recurrent Herpes Labialis

Treatments: Drug: Docosanol Cream 10%; Drug: BOR15001L7

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03977792

BOR-15001L7-P2

Details and patient eligibility

About

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.

Full 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

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Experimental treatment

Experimental group

Description:

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

Treatment:

Drug: BOR15001L7

Comparator treatment

Active Comparator group

Description:

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

Treatment:

Drug: Docosanol Cream 10%