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

Phase 1

Completed

• Conditions: Contact Dermatitis
• Interventions: Drug: BBI-2000; Drug: Vehicle; Other: Multiple treatments

• Registration Number: NCT03089775
• Lead Sponsor: Fresh Tracks Therapeutics, 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.

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 Timeline

• Study Start: 2017-03-14
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2017-05-24
• Study Completion: 2017-05-24
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BBI-2000	BBI-2000	Cohort A
Vehicle	Vehicle	Cohort A
Multiple treatments	BBI-2000	Cohort B
Multiple treatments	Vehicle	Cohort B
Multiple treatments	Multiple treatments	Cohort B

Primary Outcome Measures

Name	Time	Method
Number of adverse events in each study group	4 weeks	Comparison of the number and severity of adverse event between study groups
Vital signs, physical examinations, ECG, blood analysis, urine analysis	4 weeks	Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
Size of contact hypersensitivity reaction	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

Name	Time	Method
Dermal thickness	4 weeks	Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner
Diameter (mm) of the contact hypersensitivity area	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

Trial Locations

Locations (1)

Innovaderm Research Inc.; 🇨🇦 Montreal, Quebec, Canada