An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
- Registration Number
- NCT03977792
- Lead Sponsor
- Laboratoire Boreaderme Inc.
- 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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 164
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator treatment Docosanol Cream 10% Subjects treated with Docosanol 10%. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%. Experimental treatment BOR15001L7 Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.
- Primary Outcome Measures
Name Time Method The mean change of healing time Day 1 to 12
- Secondary Outcome Measures
Name Time Method The change in lesion rates following the prodromal stage 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 Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects] 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 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 The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages Day 1 to 12