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

Fresh Tracks Therapeutics

Status and phase: Completed; Phase 1

Conditions: Contact Dermatitis

Treatments: Other: Multiple treatments; Drug: Vehicle; Drug: BBI-2000

Study type: Interventional

Funder types: Industry

Identifiers

NCT03089775

BBI-2000-CL-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 3 patient groups, including a placebo group

BBI-2000

Experimental group

Description:

Cohort A

Treatment:

Drug: BBI-2000

Vehicle

Placebo Comparator group

Description:

Cohort A

Treatment:

Drug: Vehicle

Multiple treatments

Other group

Description:

Cohort B

Treatment:

Other: Multiple treatments

Drug: Vehicle

Drug: BBI-2000