NCT03977792

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

May 29, 2019

Last Update Submit

September 4, 2020

Conditions

Recurrent Herpes Labialis

Keywords

Herpes SimplexSkin Diseases, InfectiousHerpesviridae Infections

Outcome Measures

Primary Outcomes (1)

  • The mean change of healing time

    Day 1 to 12

Secondary Outcomes (7)

  • The change in lesion rates following the prodromal stage

    Day 1 to 12

  • The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions

    Day 1 to 12

  • The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages

    Day 1 to 12

  • The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages

    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

    Day 1 to 12

  • +2 more secondary outcomes

Study Arms (2)

Experimental treatment

EXPERIMENTAL

Subjects treated with BOR15001L7. All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.

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%.

Drug: Docosanol Cream 10%

Interventions

BOR15001L7DRUG

BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.

Experimental treatment
Docosanol Cream 10%DRUG

Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.

Comparator treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28228101BACKGROUND

MeSH Terms

Conditions

Herpes LabialisHerpes SimplexSkin Diseases, InfectiousHerpesviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Etienne Khoury, PhD, CCRP

CONTACT

(418) 545-1252etienne.khoury@ecogene21.org

Diane Brisson, PhD, CCRP

CONTACT

(418) 545-1252diane.brisson@ecogene21.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 6, 2019

Study Start

September 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

September 7, 2020

Record last verified: 2020-09