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

Study Overview
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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.

Official Title
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An Investigator Initiated Study to Evaluate the Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions In Healthy Adult Male Subjects

Conditions
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Allergic Contact Dermatitis

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Taking Baricitinib 2 mg<br>Subjects will be taking Baricitinib 2mg | Drug: Baricitinib<br>* Baricitinib 2 mg<br>|
| Placebo Comparator: Subjects Taking Placebo<br>Subjects will be taking placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement. | Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions. | Day 28 | 
| Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size. | Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions. | Day 28 | 
| Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile. | Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with reduced pruritus associated with DTH versus irritant skin reactions. | Investigator will assess pruritus reduction associated with DTH versus irritant skin reactions by a daily itch rating scale questionnaire. | Day 28 |