Herpes LabialisNCT02582086
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
A study testing BOR15001L7 in people with Herpes Labialis, run by Laboratoire Boreaderme Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- BOR15001L7
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Evalulab Inc
Montreal, Quebec, H4P 1P7
Elisabeth EF Fiquet, M. Sc., 5143430001 ext. 206, efiquet@evalulab.com
About this study
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
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
- Being tested
- BOR15001L7, Placebo
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOR15001L7Other
Active cream with 5% 15019L0
PlaceboOther
Placebo Cream with 0% 15019L0
| Study group | Role | What they receive |
|---|---|---|
| BOR15001L7 Cream | Experimental | BOR15001L7 Cream with 5% 15019L0 Receives: Other: BOR15001L7 |
| Placebo Cream | Placebo comparator | Placebo Cream Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing as assessed by the investigator
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire Boreaderme Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582086
- Sponsor's protocol ID
- 15E-0601
- Status last verified
- Mar 2017
- First submitted
- 16 Oct 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02582086
- Acronym / sponsor ID
- 15E-0601
- Conditions
- Herpes Labialis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laboratoire Boreaderme Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOR15001L7 Cream | Experimental | Other: BOR15001L7BOR15001L7 Cream with 5% 15019L0 |
| Placebo Cream | Placebo comparator | Other: PlaceboPlacebo Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOR15001L7Active cream with 5% 15019L0 | Other | BOR15001L7 Cream |
| PlaceboPlacebo Cream with 0% 15019L0 | Other | Placebo Cream |
Primary outcome
Time to healing as assessed by the investigator
Time frame: up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOR15001L7 in people with Herpes Labialis, run by Laboratoire Boreaderme Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth EF Fiquet, M. Sc (5143430001 ext. 206, efiquet@evalulab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to healing as assessed by the investigator (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.