Herpes Labialis
Conditions
Brief summary
The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.
Interventions
OTHERBOR15001L7
Active cream with 5% 15019L0
OTHERPlacebo
Placebo Cream with 0% 15019L0
Sponsors
Laboratoire Boreaderme Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female and male, in good health, 18 years of age or older, * With history of recurrent herpes labialis with at least twice a year during the past twenty-four months, * Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids, * Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol, * Must be willing and able to participate and to provide written informed consent, * Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
Exclusion criteria
* Volunteers who refuse to introduce the product to be tested in its routine, * With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil), * Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested, * Who suffer from a serious illness or health problem or a critical or progressive disease, * Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories…) within 7 days prior to study beginning, * Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study, * Who abuse alcohol, drugs and/or tobacco, * Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to healing as assessed by the investigator | up to 10 days |
Countries
Canada
Contacts
Primary ContactElisabeth EF Fiquet, M. Sc
Outcome results
None listed