Recurrent Herpes LabialisPhase 2NCT03977792
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
A Phase 2 study testing BOR15001L7 and Docosanol Cream 10% in people with Recurrent Herpes Labialis, run by Laboratoire Boreaderme Inc..
Trial summary
BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Herpes Labialis
- What is being tested?
- BOR15001L7 and Docosanol Cream 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Jul 2022
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent and willing to comply with study-related procedures;
- Males and females ≥18 years of age at screening;
- Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
- Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
- Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.
Who cannot join
- Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
- Patients with herpes labialis occurring within 14 days prior to screening;
- Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
- Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
- Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis
BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
Read the detailed description
Secondary objectives are to:
- Evaluate the efficacy of BOR1500L7 on:
- The reduction of ulcerative lesions rates following the prodromal stage;
- The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;
- The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;
- The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;
- The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;
- Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis
- Conditions
- Recurrent Herpes Labialis
- Being tested
- BOR15001L7, Docosanol Cream 10%
- Keywords
- Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections
- Medical subject headings
- Herpes Labialis, Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOR15001L7Drug
BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
Docosanol Cream 10%Drug
Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental treatment | Experimental | Subjects treated with BOR15001L7.
All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%. Receives: Drug: BOR15001L7 |
| Comparator treatment | Active comparator | Subjects treated with Docosanol 10%.
All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%. Receives: Drug: Docosanol Cream 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of healing time
Measured: Day 1 to 12
Secondary outcomes (7)
The change in lesion rates following the prodromal stage
Measured: Day 1 to 12
The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions
Measured: Day 1 to 12
The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Measured: Day 1 to 12
The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Measured: Day 1 to 12
The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Measured: Day 1 to 12
The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Measured: Day 1 to 12
Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]
Measured: Day 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study startSep 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire Boreaderme Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ecogene 21
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977792
- Sponsor's protocol ID
- BOR-15001L7-P2
- Status last verified
- Sep 2020
- First submitted
- 29 May 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lavoie S, Cote I, Pichette A, Gauthier C, Ouellet M, Nagau-Lavoie F, Mshvildadze V, Legault J. Chemical composition and anti-herpes simplex virus type 1 (HSV-1) activity of extracts from Cornus canadensis. BMC Complement Altern Med. 2017 Feb 22;17(1):123. doi: 10.1186/s12906-017-1618-2.
PubMed 28228101
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis
- ClinicalTrials.gov ID
- NCT03977792
- Acronym / sponsor ID
- BOR-15001L7-P2
- Conditions
- Recurrent Herpes Labialis
- Keywords
- Herpes Simplex, Skin Diseases, Infectious, Herpesviridae Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Laboratoire Boreaderme Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ecogene 21
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 6 Jun 2019 (actual)
- 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.
BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
Detailed description
Secondary objectives are to:
- Evaluate the efficacy of BOR1500L7 on:
- The reduction of ulcerative lesions rates following the prodromal stage;
- The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;
- The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;
- The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;
- The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;
- Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental treatment | Experimental | Drug: BOR15001L7Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%. |
| Comparator treatment | Active comparator | Drug: Docosanol Cream 10%Subjects treated with Docosanol 10%. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide signed informed consent and willing to comply with study-related procedures;
- Males and females ≥18 years of age at screening;
- Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
- Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
- Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.
Key exclusion criteria (5 listed)
- Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
- Patients with herpes labialis occurring within 14 days prior to screening;
- Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
- Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
- Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
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 |
|---|---|---|
| BOR15001L7BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection. | Drug | Experimental treatment |
| Docosanol Cream 10%Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection. | Drug | Comparator treatment |
Primary outcome
The mean change of healing time
Time frame: Day 1 to 12
7 secondary outcomes
The change in lesion rates following the prodromal stage
Time frame: Day 1 to 12
The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions
Time frame: Day 1 to 12
The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages
Time frame: Day 1 to 12
Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]
Time frame: Day 1 to 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 28228101Lavoie S, Cote I, Pichette A, Gauthier C, Ouellet M, Nagau-Lavoie F, Mshvildadze V, Legault J. Chemical composition and anti-herpes simplex virus type 1 (HSV-1) activity of extracts from Cornus canadensis. BMC Complement Altern Med. 2017 Feb 22;17(1):123. doi: 10.1186/s12906-017-1618-2.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BOR15001L7 and Docosanol Cream 10% in people with Recurrent Herpes Labialis, run by Laboratoire Boreaderme Inc..
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 5 inclusion and 5 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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Etienne Khoury, PhD, CCRP ((418) 545-1252 ext. 239, etienne.khoury@ecogene21.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change of healing time (time frame: Day 1 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977792, which also lists 1 linked publication.
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 7 Sep 2020.