Recruiting

Natural Health Product

Sponsor:

Laboratoire Boreaderme Inc.

Code:

NCT02582086

Conditions

Herpes Labialis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

BOR15001L7

Placebo

Study Details

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

Study ID

NCT02582086

Start date

Jan, 2016

Status verified date

Mar, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BOR15001L7 Cream

BOR15001L7 Cream with 5% 15019L0

placebo comparator: Placebo Cream

Placebo Cream

Interventions

BOR15001L7

Active cream with 5% 15019L0

Placebo

Placebo Cream with 0% 15019L0

Primary outcome measure

  • Time to healing as assessed by the investigator [ Time Frame: up to 10 days ]

Central Contacts and Locations

Central contacts

Elisabeth EF Fiquet, M. Sc

5143430001efiquet@evalulab.com

Locations

Evalulab Inc

Recruiting

Montréal, Quebec, Canada, H4P 1P7

Contacts

Elisabeth EF Fiquet, M. Sc.

5143430001efiquet@evalulab.com

More Information

Sponsor

Laboratoire Boreaderme Inc.

Last update posted

Mar 9, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Laboratoire Boreaderme Inc. on 2017-03-09.