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

Contact Dermatitis Clinical Trial

— BBI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089775
• Other study ID #: BBI-2000-CL-101
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2017
• Last updated: July 13, 2017
• Start date: March 14, 2017
• Est. completion date: May 24, 2017

Study information

• Verified date: July 2017
• Source: Brickell Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 24, 2017
• Est. primary completion date: May 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact

Intervention

Drug:
• BBI-2000
Experimental
• Vehicle
Vehicle Comparator

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

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Brickell Biotech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events in each study group	Comparison of the number and severity of adverse event between study groups	4 weeks
Primary	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
Primary	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	Dermal thickness	Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner	4 weeks
Secondary	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