CClinicalTrials.gg
Status unknownNCT02582086Updated Mar 9, 2017

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

An interventional study of BOR15001L7 and Placebo in Herpes Labialis, sponsored by Laboratoire Boreaderme Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-09.

Sponsored by Laboratoire Boreaderme Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Herpes Labialis
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's planned enrollment of 40 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Laboratoire Boreaderme Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    BOR15001L7 Cream

    BOR15001L7 Cream with 5% 15019L0

    Other: BOR15001L7

  • Placebo comparator
    Placebo Cream

    Placebo Cream

    Other: Placebo

Interventions

  • OtherBOR15001L7

    Active cream with 5% 15019L0

  • OtherPlacebo

    Placebo Cream with 0% 15019L0

06

What researchers measure

Primary outcomes

  1. Time to healing as assessed by the investigator

    Time frame: up to 10 days

07

Study locations

1 of 1 sites recruiting
  • Evalulab Inc
    Montréal, Quebec H4P 1P7, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02582086
Lead sponsor
Laboratoire Boreaderme Inc.
Responsible party
Sponsor
First posted
Oct 21, 2015
Start date
Jan 2016
Primary completion
Sep 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Mar 9, 2017

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion