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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Study to Evaluate the Effect of Topically Applied BBI-2000 (5%) on Allergic Responses in Subjects With Contact Hypersensitivity to Diphencyprone

Conditions
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Contact Dermatitis

Intervention / Treatment
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* Drug: BBI-2000
* Drug: Vehicle
* Other: Multiple treatments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBI-2000<br>Cohort A | Drug: BBI-2000<br>* Experimental<br>|
| Placebo Comparator: Vehicle<br>Cohort A | Drug: Vehicle<br>* Vehicle Comparator<br>|
| Other: Multiple treatments<br>Cohort B | Drug: BBI-2000<br>* Experimental<br>Drug: Vehicle<br>* Vehicle Comparator<br>Other: Multiple treatments<br>* BBI-2000, Vehicle, Clobetasol Propionate, No treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal thickness | Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner | 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 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact, Treatment, Prevention, BBI-2000, Dermatitis, Allergic