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

NCT03945760 | Completed Early Phase 1 FDA Drug

• 1 other identifier: I4V-US-O007
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Contact Dermatitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  Day 28

Study Arms (2)

Subjects Taking Baricitinib 2 mg

EXPERIMENTAL

Subjects will be taking Baricitinib 2mg

Drug: Baricitinib

Subjects Taking Placebo

PLACEBO COMPARATOR

Subjects will be taking placebo

Drug: Placebo

Interventions

Baricitinib DRUG

Baricitinib 2 mg

Subjects Taking Baricitinib 2 mg

Placebo DRUG

Placebo

Subjects Taking Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State Physicians: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Interventions

baricitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 10, 2019
• Study Start: September 14, 2020
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

US (1)