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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Contact Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wright State Physicians
• Investigators: Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State Physicians

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Skin Diseases, Eczematous; Hypersensitivity; Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Hypersensitivity, Delayed
• Other Study ID Numbers: I4V-US-O007

Drug and device information, study documents

• 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