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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582086
Recruitment Status : Unknown
Verified March 2017 by Laboratoire Boreaderme Inc..
Recruitment status was:  Recruiting
First Posted : October 21, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Laboratoire Boreaderme Inc.

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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Other: BOR15001L7 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Experimental: BOR15001L7 Cream
BOR15001L7 Cream with 5% 15019L0
Other: BOR15001L7
Active cream with 5% 15019L0

Placebo Comparator: Placebo Cream
Placebo Cream
Other: Placebo
Placebo Cream with 0% 15019L0




Primary Outcome Measures :
  1. Time to healing as assessed by the investigator [ Time Frame: up to 10 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582086


Contacts
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Contact: Elisabeth EF Fiquet, M. Sc 5143430001 ext 206 efiquet@evalulab.com

Locations
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Canada, Quebec
Evalulab Inc Recruiting
Montréal, Quebec, Canada, H4P 1P7
Contact: Elisabeth EF Fiquet, M. Sc.    5143430001 ext 206    efiquet@evalulab.com   
Sponsors and Collaborators
Laboratoire Boreaderme Inc.
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Responsible Party: Laboratoire Boreaderme Inc.
ClinicalTrials.gov Identifier: NCT02582086    
Other Study ID Numbers: 15E-0601
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases