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

Herpes Labialis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582086
• Other study ID #: 15E-0601
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2015
• Last updated: March 7, 2017
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: Laboratoire Boreaderme Inc.
• Contact: Elisabeth EF Fiquet, M. Sc
• Phone: 5143430001
• Email: efiquet[@]evalulab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

Other:
• BOR15001L7
Active cream with 5% 15019L0
• Placebo
Placebo Cream with 0% 15019L0

Locations

Country	Name	City	State
Canada	Evalulab Inc	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire Boreaderme Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing as assessed by the investigator		up to 10 days