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 — DRUGBaricitinib 2 mg
- Placebo — DRUGPlacebo
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 mgSubjects will be taking Baricitinib 2mg
- Placebo Comparator: Subjects Taking PlaceboSubjects 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wright State Physicians | Fairborn | Ohio | 45324 | - |
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