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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03089775
Other study ID # BBI-2000-CL-101
Secondary ID
Status Completed
Phase Phase 1
First received March 15, 2017
Last updated July 13, 2017
Start date March 14, 2017
Est. completion date May 24, 2017

Study information

Verified date July 2017
Source Brickell Biotech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date May 24, 2017
Est. primary completion date May 24, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BBI-2000
Experimental
Vehicle
Vehicle Comparator
Other:
Multiple treatments
BBI-2000, Vehicle, Clobetasol Propionate, No treatment

Locations

Country Name City State
Canada Innovaderm Research Inc. Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Brickell Biotech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events in each study group Comparison of the number and severity of adverse event between study groups 4 weeks
Primary 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
Primary 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 Dermal thickness Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner 4 weeks
Secondary 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 4 weeks
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