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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Contact: Regulatory Specialist; 937-245-7500; pturesearch@wrightstatephysicians.org

Locations

United States, Ohio

Wright State Physicians

Fairborn, Ohio, United States, 45324

Sponsors and Collaborators

Wright State Physicians

Investigators

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

More Information

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

• 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:

Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Hypersensitivity; Hypersensitivity, Delayed; Skin Diseases; Immune System Diseases; Skin Diseases, Eczematous