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Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis (BBI)

Primary Purpose

Contact Dermatitis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
BBI-2000
Vehicle
Multiple treatments
Sponsored by
Fresh Tracks Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Dermatitis focused on measuring Contact, Treatment, Prevention, BBI-2000, Dermatitis, Allergic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Innovaderm Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

BBI-2000

Vehicle

Multiple treatments

Arm Description

Cohort A

Cohort A

Cohort B

Outcomes

Primary Outcome Measures

Number of adverse events in each study group
Comparison of the number and severity of adverse event between study groups
Vital signs, physical examinations, ECG, blood analysis, urine analysis
Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
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

Secondary Outcome Measures

Dermal thickness
Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
Diameter (mm) of the contact hypersensitivity area
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for areas randomized to BBI-2000, as compared with vehicle, no treatment, and clobetasol propionate over time

Full Information

First Posted
March 15, 2017
Last Updated
July 13, 2017
Sponsor
Fresh Tracks Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03089775
Brief Title
Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis
Acronym
BBI
Official Title
A Randomized, Controlled Study to Evaluate the Effect of Topically Applied BBI-2000 (5%) on Allergic Responses in Subjects With Contact Hypersensitivity to Diphencyprone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
May 24, 2017 (Actual)
Study Completion Date
May 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresh Tracks Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This two cohort (Cohort A and B) single-center, randomized, controlled study is being conducted to evaluate the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity (DTH) reactions. Subjects in Cohort A will initially receive either pre-treatment with BBI-2000 or vehicle, on an area on the back. Diphencyprone (DPCP) will then be administered, via Finn chamber, to the same area on the back. The treated area will then be assessed to determine if BBI-2000 was effective in preventing a contact hypersensitivity reaction. Cohort B will first be sensitized with DPCP as in Cohort A. Indicated regions of the back will then be challenged to illicit a DTH reaction. Following the challenge, indicated regions on the subject's back will be treated with either (A) BBI-2000, (B) vehicle, (C) no topical application or (D) clobetasol propionate. The efficacy of BBI-2000 will be evaluated by monitoring response of the area of contact hypersensitivity reaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
Keywords
Contact, Treatment, Prevention, BBI-2000, Dermatitis, Allergic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBI-2000
Arm Type
Experimental
Arm Description
Cohort A
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Cohort A
Arm Title
Multiple treatments
Arm Type
Other
Arm Description
Cohort B
Intervention Type
Drug
Intervention Name(s)
BBI-2000
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle Comparator
Intervention Type
Other
Intervention Name(s)
Multiple treatments
Intervention Description
BBI-2000, Vehicle, Clobetasol Propionate, No treatment
Primary Outcome Measure Information:
Title
Number of adverse events in each study group
Description
Comparison of the number and severity of adverse event between study groups
Time Frame
4 weeks
Title
Vital signs, physical examinations, ECG, blood analysis, urine analysis
Description
Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
Time Frame
4 weeks
Title
Size of contact hypersensitivity reaction
Description
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Dermal thickness
Description
Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
Time Frame
4 weeks
Title
Diameter (mm) of the contact hypersensitivity area
Description
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for areas randomized to BBI-2000, as compared with vehicle, no treatment, and clobetasol propionate over time
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A Romel, MS
Organizational Affiliation
Fresh Tracks Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis

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