NCT03089775

Brief Summary

This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity reaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 14, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

March 15, 2017

Last Update Submit

July 13, 2017

Conditions

Contact Dermatitis

Keywords

ContactTreatmentPreventionBBI-2000DermatitisAllergic

Outcome Measures

Primary Outcomes (3)

  • Number of adverse events in each study group

    Comparison of the number and severity of adverse event between study groups

    4 weeks

  • Vital signs, physical examinations, ECG, blood analysis, urine analysis

    Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups

    4 weeks

  • Size of contact hypersensitivity reaction

    Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle

    4 weeks

Secondary Outcomes (2)

  • Dermal thickness

    4 weeks

  • Diameter (mm) of the contact hypersensitivity area

    4 weeks

Study Arms (3)

BBI-2000

EXPERIMENTAL

Cohort A

Drug: BBI-2000

Vehicle

PLACEBO COMPARATOR

Cohort A

Drug: Vehicle

Multiple treatments

OTHER

Cohort B

Drug: BBI-2000Drug: VehicleOther: Multiple treatments

Interventions

BBI-2000DRUG

Experimental

BBI-2000Multiple treatments
VehicleDRUG

Vehicle Comparator

Multiple treatmentsVehicle
Multiple treatmentsOTHER

BBI-2000, Vehicle, Clobetasol Propionate, No treatment

Multiple treatments

Eligibility Criteria

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

You may qualify if:

  • Individuals aged 18 to 65 years inclusive at the time of consent, and either female of non-reproductive potential or male.
  • Subjects must be healthy, normal volunteers per physical exam, laboratory and EKG assessments

You may not qualify if:

  • History of contact dermatitis to medical adhesive bandages or glue.
  • Medical history of dermatographism.
  • Any medical condition causing immunosuppression.
  • Prior treatment or therapies or history of sensitivity to any of the study products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, ContactDermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Lawrence A Romel, MS

    Fresh Tracks Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 24, 2017

Study Start

March 14, 2017

Primary Completion

May 24, 2017

Study Completion

May 24, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)