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

  • End date
    Dec 25, 2022
  • participants needed
  • sponsor
    Wright State Physicians
Updated on 25 March 2022
atopic dermatitis
allergic contact dermatitis
Accepts healthy volunteers


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.

Condition Allergic Contact Dermatitis
Treatment Placebo, Baricitinib
Clinical Study IdentifierNCT03945760
SponsorWright State Physicians
Last Modified on25 March 2022


Yes No Not Sure

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
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
Clear my responses

How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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