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

Allergic Contact Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945760
• Other study ID #: I4V-US-O007
• Status: Completed
• Phase: Early Phase 1
• Start date: September 14, 2020
• Est. completion date: October 16, 2023

Study information

• Verified date: December 2023
• Source: Wright State Physicians
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact
• Hypersensitivity
• Hypersensitivity, Delayed

Intervention

Drug:
• Baricitinib
Baricitinib 2 mg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State Physicians

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.	Investigator will assess pruritus reduction associated with DTH versus irritant skin reactions by a daily itch rating scale questionnaire.	Day 28