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

Not Applicable

• Conditions: Herpes Labialis
• Interventions: Other: Placebo; Other: BOR15001L7

• Registration Number: NCT02582086
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Study Start: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Cream	Placebo	Placebo Cream
BOR15001L7 Cream	BOR15001L7	BOR15001L7 Cream with 5% 15019L0

Primary Outcome Measures

Name	Time	Method
Time to healing as assessed by the investigator	up to 10 days

Trial Locations

Locations (1)

Evalulab Inc; 🇨🇦 Montréal, Quebec, Canada