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

NCT ID: NCT02582086

Last Updated: 2017-03-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Herpes Labialis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BOR15001L7 Cream

BOR15001L7 Cream with 5% 15019L0

Group Type EXPERIMENTAL

BOR15001L7

Intervention Type OTHER

Active cream with 5% 15019L0

Placebo Cream

Placebo Cream

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Cream with 0% 15019L0

Interventions

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BOR15001L7

Active cream with 5% 15019L0

Intervention Type OTHER

Placebo

Placebo Cream with 0% 15019L0

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laboratoire Boreaderme Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evalulab Inc

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Elisabeth EF Fiquet, M. Sc

Role: CONTACT

5143430001 ext. 206

Facility Contacts

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Elisabeth EF Fiquet, M. Sc.

Role: primary

5143430001 ext. 206

Other Identifiers

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15E-0601

Identifier Type: -

Identifier Source: org_study_id

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