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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoire Boreaderme Inc.
• Collaborator: Ecogene 21
• Treatments: Docosanol

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.