Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
Primary Purpose
Herpes Labialis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BOR15001L7
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Labialis
Eligibility Criteria
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.
Sites / Locations
- Evalulab IncRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BOR15001L7 Cream
Placebo Cream
Arm Description
BOR15001L7 Cream with 5% 15019L0
Placebo Cream
Outcomes
Primary Outcome Measures
Time to healing as assessed by the investigator
Secondary Outcome Measures
Full Information
NCT ID
NCT02582086
First Posted
October 16, 2015
Last Updated
March 7, 2017
Sponsor
Laboratoire Boreaderme Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02582086
Brief Title
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire Boreaderme Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Labialis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BOR15001L7 Cream
Arm Type
Experimental
Arm Description
BOR15001L7 Cream with 5% 15019L0
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
Placebo Cream
Intervention Type
Other
Intervention Name(s)
BOR15001L7
Intervention Description
Active cream with 5% 15019L0
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Cream with 0% 15019L0
Primary Outcome Measure Information:
Title
Time to healing as assessed by the investigator
Time Frame
up to 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth EF Fiquet, M. Sc
Phone
5143430001
Ext
206
Email
efiquet@evalulab.com
Facility Information:
Facility Name
Evalulab Inc
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4P 1P7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth EF Fiquet, M. Sc.
Phone
5143430001
Ext
206
Email
efiquet@evalulab.com
12. IPD Sharing Statement
Learn more about this trial
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
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