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NCT Number: NCT03945760

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

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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Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Baricitinib

Drug

Baricitinib 2 mg

Placebo

Drug

Placebo

Primary outcomes

  1. Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.

    Time frame: Day 28

    Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions.

  2. Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.

    Time frame: Day 28

    Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions.

  3. Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.

    Time frame: Day 28

    Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions.

Secondary outcomes

  1. Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.

    Time frame: Day 28

    Investigator will assess pruritus reduction associated with DTH versus irritant skin reactions by a daily itch rating scale questionnaire.

Sponsors and collaborators

Lead sponsor

Wright State Physicians

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 10, 2019
Registry last updated
Dec 5, 2023

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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