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

Part of paid clinical trials in Fairborn, Ohio.

Sponsor
Wright State Physicians
Study ID
NCT03945760
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Allergic Contact Dermatitis

Eligibility Criteria

Sex
MALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Baricitinib — DRUG
    Baricitinib 2 mg
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Dec 2023
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects Taking Baricitinib 2 mg
    Subjects will be taking Baricitinib 2mg
  • Placebo Comparator: Subjects Taking Placebo
    Subjects will be taking placebo

Primary Outcome Measure

Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement. [ Time Frame: Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wright State PhysiciansFairbornOhio45324-

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