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

NCT02582086 | Unknown

• 1 other identifier: 15E-0601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

• Time to healing as assessed by the investigator

  up to 10 days

Study Arms (2)

BOR15001L7 Cream

EXPERIMENTAL

BOR15001L7 Cream with 5% 15019L0

Other: BOR15001L7

Placebo Cream

PLACEBO COMPARATOR

Placebo Cream

Other: Placebo

Interventions

BOR15001L7 OTHER

Active cream with 5% 15019L0

BOR15001L7 Cream

Placebo OTHER

Placebo Cream with 0% 15019L0

Placebo Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoire Boreaderme Inc.: lead

Study Sites (1)

Evalulab Inc

Montreal, Quebec, H4P 1P7, Canada

RECRUITING

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Elisabeth EF Fiquet, M. Sc

CONTACT

5143430001; efiquet@evalulab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

CA (1)