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NCT Number: NCT03089775

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

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.

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Key information

Conditions

Contact Dermatitis Dermatitis Dermatitis, Contact Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BBI-2000

Drug

Experimental

Vehicle

Drug

Vehicle Comparator

Multiple treatments

Other

BBI-2000, Vehicle, Clobetasol Propionate, No treatment

Primary outcomes

  1. Number of adverse events in each study group

    Time frame: 4 weeks

    Comparison of the number and severity of adverse event between study groups

  2. Vital signs, physical examinations, ECG, blood analysis, urine analysis

    Time frame: 4 weeks

    Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups

  3. Size of contact hypersensitivity reaction

    Time frame: 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 outcomes

  1. Dermal thickness

    Time frame: 4 weeks

    Contact hypersensitivity reactions will be quantified using a high-frequency 20-Megahertz (MHz) ultrasound scanner

  2. Diameter (mm) of the contact hypersensitivity area

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fresh Tracks Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: BBI

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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