search
Back to results

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

Primary Purpose

Allergic Contact Dermatitis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
Wright State Physicians
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wright State PhysiciansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Subjects Taking Baricitinib 2 mg

Subjects Taking Placebo

Arm Description

Subjects will be taking Baricitinib 2mg

Subjects will be taking placebo

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 26, 2019
Last Updated
January 27, 2022
Sponsor
Wright State Physicians
search

1. Study Identification

Unique Protocol Identification Number
NCT03945760
Brief Title
Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State Physicians

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects Taking Baricitinib 2 mg
Arm Type
Experimental
Arm Description
Subjects will be taking Baricitinib 2mg
Arm Title
Subjects Taking Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be taking placebo
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Intervention Description
Baricitinib 2 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.
Description
Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions.
Time Frame
Day 28
Title
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.
Description
Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions.
Time Frame
Day 28
Title
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
Description
Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.
Description
Investigator will assess pruritus reduction associated with DTH versus irritant skin reactions by a daily itch rating scale questionnaire.
Time Frame
Day 28

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager, Clinical Research Operations
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Specialist
Phone
937-245-7500
Email
pturesearch@wrightstatephysicians.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey B Travers, MD, PhD
Organizational Affiliation
Wright State Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs