Clinical trial NCT03945760: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Allergic Contact Dermatitis
Lead sponsor: Wright State Physicians
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.
timeFrame: Day 28
measure: Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.
timeFrame: Day 28
measure: Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
timeFrame: Day 28
Secondary outcomes:
measure: Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.
timeFrame: Day 28
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State Physicians
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: