Clinical trial NCT03089775: Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contact Dermatitis
Keywords: Contact
Treatment
Prevention
BBI-2000
Dermatitis
Allergic
Lead sponsor: Fresh Tracks Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of adverse events in each study group
timeFrame: 4 weeks
measure: Vital signs, physical examinations, ECG, blood analysis, urine analysis
timeFrame: 4 weeks
measure: Size of contact hypersensitivity reaction
timeFrame: 4 weeks
Secondary outcomes:
measure: Dermal thickness
timeFrame: 4 weeks
measure: Diameter (mm) of the contact hypersensitivity area
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Fresh Tracks Therapeutics, Inc.
name: Lawrence A Romel, MS
role: STUDY_DIRECTOR
References: