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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
Sponsor:
Information provided by (Responsible Party):
Brickell Biotech, Inc.

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.

Condition or disease Intervention/treatment Phase
Contact Dermatitis Drug: BBI-2000 Drug: Vehicle Other: Multiple treatments Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: BBI-2000
Cohort A
Drug: BBI-2000
Experimental

Placebo Comparator: Vehicle
Cohort A
Drug: Vehicle
Vehicle Comparator

Multiple treatments
Cohort B
Drug: BBI-2000
Experimental

Drug: Vehicle
Vehicle Comparator

Other: Multiple treatments
BBI-2000, Vehicle, Clobetasol Propionate, No treatment




Primary Outcome Measures :
  1. Number of adverse events in each study group [ Time Frame: 4 weeks ]
    Comparison of the number and severity of adverse event between study groups

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Dermal thickness [ Time Frame: 4 weeks ]
    Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Brickell Biotech, Inc.
Investigators
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Study Director: Lawrence A Romel, MS Brickell Biotech, Inc.

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Responsible Party: Brickell Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03089775     History of Changes
Other Study ID Numbers: BBI-2000-CL-101
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brickell Biotech, Inc.:
Contact
Treatment
Prevention
BBI-2000
Dermatitis
Allergic
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous