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

March 7, 2017 updated by: Laboratoire Boreaderme Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4P 1P7
        • Recruiting
        • Evalulab Inc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BOR15001L7 Cream
BOR15001L7 Cream with 5% 15019L0
Other: BOR15001L7
Active cream with 5% 15019L0
PLACEBO_COMPARATOR: Placebo Cream
Other: Placebo
Placebo Cream with 0% 15019L0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to healing as assessed by the investigator
Time Frame: up to 10 days
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoire Boreaderme Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2017

Study Completion (ANTICIPATED)

September 1, 2017

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15E-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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