Recurrent Herpes Labialis
Conditions
Keywords
Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections
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
Interventions
DRUGBOR15001L7
BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
DRUGDocosanol Cream 10%
Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
Sponsors
Ecogene 21
Laboratoire Boreaderme Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change of healing time | Day 1 to 12 |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages | 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 |
| 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 delays (hours) between the prodromal stage and the first visible occurence of lesions | 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 |
| Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects] | Day 1 to 12 |
| The change in lesion rates following the prodromal stage | Day 1 to 12 |
Contacts
Primary ContactEtienne Khoury, PhD, CCRP
Backup ContactDiane Brisson, PhD, CCRP
Outcome results
None listed