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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
Experimental
Vehicle Comparator
BBI-2000, Vehicle, Clobetasol Propionate, No treatment
Innovaderm Research Inc.
Montreal, Quebec, Canada
Number of adverse events in each study group
Comparison of the number and severity of adverse event between study groups
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Dermal thickness
Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
Time frame: 4 weeks
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
Time frame: 4 weeks
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