An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold S… (NCT03977792) | Clinical Trial Compass
UnknownPhase 2
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
164 participantsStarted 2020-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 halfË—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.