Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
NCT ID: NCT02582086
Last Updated: 2017-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2016-01-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BOR15001L7 Cream
BOR15001L7 Cream with 5% 15019L0
BOR15001L7
Active cream with 5% 15019L0
Placebo Cream
Placebo Cream
Placebo
Placebo Cream with 0% 15019L0
Interventions
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BOR15001L7
Active cream with 5% 15019L0
Placebo
Placebo Cream with 0% 15019L0
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Laboratoire Boreaderme Inc.
INDUSTRY
Responsible Party
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Locations
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Evalulab Inc
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15E-0601
Identifier Type: -
Identifier Source: org_study_id
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