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Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects

NCT ID: NCT03945760

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-10-16

Brief Summary

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The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed.

This research study explores the effectiveness of Baricitinib in treating Delayed-Type Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to be healthy males between the ages of 18 and 40. This study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of Baricitinib by skin and blood testing.

Detailed Description

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Conditions

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Allergic Contact Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Subjects Taking Baricitinib 2 mg

Subjects will be taking Baricitinib 2mg

Group Type EXPERIMENTAL

Baricitinib

Intervention Type DRUG

Baricitinib 2 mg

Subjects Taking Placebo

Subjects will be taking placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Baricitinib

Baricitinib 2 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males 18-40 years of age at the time of signing the informed consent document
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
* Able to adhere to the study visit schedule and other protocol requirements
* Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities

Exclusion Criteria

* Any known severe allergies to yeast products
* Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
* Inability to understand informed consent
* Any medical condition that the investigator feels would interfere with study
* Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
* Agree to discontinue use of prohibited medications at least 4 weeks prior to screening:

topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines

* Positive reaction to tuberculin test (PPD) or negative control
* Negative reaction to initial skin testing for Candida, Trichophyton, or Sodium Laurel Sulfate
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wright State Physicians

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State Physicians

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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I4V-US-O007

Identifier Type: -

Identifier Source: org_study_id