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.

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

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.