Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Topical Natural Health Product for the Treatment of Herpes Labialis

Conditions
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Herpes Labialis

Intervention / Treatment
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* Other: BOR15001L7
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOR15001L7 Cream<br>BOR15001L7 Cream with 5% 15019L0 | Other: BOR15001L7<br>* Active cream with 5% 15019L0<br>|
| Placebo Comparator: Placebo Cream<br>Placebo Cream | Other: Placebo<br>* Placebo Cream with 0% 15019L0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing as assessed by the investigator |  | up to 10 days |