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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Brickell Biotech, Inc.

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Brickell Biotech, Inc.

Dates:
Date Received: March 15, 2017
Date Started: March 14, 2017
Date Completion: October 2017
Last Updated: March 20, 2017
Last Verified: March 2017