Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis (BBI)
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|ClinicalTrials.gov Identifier: NCT03089775|
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Contact Dermatitis||Drug: BBI-2000 Drug: Vehicle Other: Multiple treatments||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 14, 2017|
|Actual Primary Completion Date :||May 24, 2017|
|Actual Study Completion Date :||May 24, 2017|
Placebo Comparator: Vehicle
Other: Multiple treatments
BBI-2000, Vehicle, Clobetasol Propionate, No treatment
- Number of adverse events in each study group [ Time Frame: 4 weeks ]Comparison of the number and severity of adverse event between study groups
- Vital signs, physical examinations, ECG, blood analysis, urine analysis [ Time Frame: 4 weeks ]Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
- Size of contact hypersensitivity reaction [ Time Frame: 4 weeks ]Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle
- Dermal thickness [ Time Frame: 4 weeks ]Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
- Diameter (mm) of the contact hypersensitivity area [ Time Frame: 4 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089775
|Innovaderm Research Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Study Director:||Lawrence A Romel, MS||Brickell Biotech, Inc.|