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Trial record 36 of 62 for:    Baricitinib

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

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ClinicalTrials.gov Identifier: NCT03945760
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Wright State Physicians

Brief Summary:

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 or disease Intervention/treatment Phase
Allergic Contact Dermatitis Drug: Baricitinib Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Subjects Taking Baricitinib 2 mg
Subjects will be taking Baricitinib 2mg
Drug: Baricitinib
Baricitinib 2 mg

Placebo Comparator: Subjects Taking Placebo
Subjects will be taking placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945760


Contacts
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Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org

Locations
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United States, Ohio
Wright State Physicians
Fairborn, Ohio, United States, 45324
Sponsors and Collaborators
Wright State Physicians
Investigators
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Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians

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Responsible Party: Wright State Physicians
ClinicalTrials.gov Identifier: NCT03945760     History of Changes
Other Study ID Numbers: I4V-US-O007
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Hypersensitivity
Hypersensitivity, Delayed
Skin Diseases
Immune System Diseases
Skin Diseases, Eczematous