Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis
NCT ID: NCT03089775
Last Updated: 2017-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2017-03-14
2017-05-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BBI-2000
Cohort A
BBI-2000
Experimental
Vehicle
Cohort A
Vehicle
Vehicle Comparator
Multiple treatments
Cohort B
BBI-2000
Experimental
Vehicle
Vehicle Comparator
Multiple treatments
BBI-2000, Vehicle, Clobetasol Propionate, No treatment
Interventions
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BBI-2000
Experimental
Vehicle
Vehicle Comparator
Multiple treatments
BBI-2000, Vehicle, Clobetasol Propionate, No treatment
Eligibility Criteria
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Inclusion Criteria
* Subjects must be healthy, normal volunteers per physical exam, laboratory and EKG assessments
Exclusion Criteria
* Medical history of dermatographism.
* Any medical condition causing immunosuppression.
* Prior treatment or therapies or history of sensitivity to any of the study products.
18 Years
65 Years
ALL
Yes
Sponsors
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Fresh Tracks Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence A Romel, MS
Role: STUDY_DIRECTOR
Fresh Tracks Therapeutics, Inc.
Locations
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Innovaderm Research Inc.
Montreal, Quebec, Canada
Countries
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Other Identifiers
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BBI-2000-CL-101
Identifier Type: -
Identifier Source: org_study_id
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