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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Taking Baricitinib 2 mg | Experimental | Subjects will be taking Baricitinib 2mg |
|
| Subjects Taking Placebo | Placebo Comparator | Subjects will be taking placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Baricitinib 2 mg |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Travers, MD, PhD | Wright State Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
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| ID | Term |
|---|---|
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Placebo |
| Drug |
Placebo |
|
| D017443 |
| Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |