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

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

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.

Study Overview

• Status: Completed
• Conditions: Contact Dermatitis
• Intervention / Treatment: Drug: Vehicle; Drug: BBI-2000; Other: Multiple treatments

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fresh Tracks Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): May 24, 2017
• Study Completion (Actual): May 24, 2017

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; Prevention; Allergic; Dermatitis; Contact; BBI-2000
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: BBI-2000-CL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No