Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03945760
Other study ID # I4V-US-O007
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05498467 - The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis Phase 3
Active, not recruiting NCT03680131 - Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis Phase 2
Recruiting NCT05535738 - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Phase 2/Phase 3
Recruiting NCT06191627 - Patient Experience and Quality of Patch Testing on the Legs vs Back N/A
Completed NCT00867607 - Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis Phase 1/Phase 2
Recruiting NCT00445029 - Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation N/A
Completed NCT04365140 - MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel
Recruiting NCT05991674 - A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
Completed NCT00931242 - Study of Apremilast in Atopic or Contact Dermatitis Phase 2
Completed NCT01798589 - Bioequivalence of Ethylenediamine Dihydrochloride Study Phase 4
Completed NCT01546298 - Immune Reactions in Contact Dermatitis Affected Skin
Completed NCT05339750 - Allergy Skin Patch Artificial Intelligence (AI) N/A
Recruiting NCT03935971 - The Effects of Dupilumab on Allergic Contact Dermatitis Phase 4
Completed NCT01797562 - Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents N/A
Not yet recruiting NCT05858723 - Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool N/A
Completed NCT02534441 - Epidemiology and Co-Reactivity of Novel Surfactant Allergens N/A
Not yet recruiting NCT01413477 - Nickel Desensitization Using Topical Therapy N/A
Completed NCT00133341 - Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate Phase 2
Completed NCT00132600 - Clinical Evaluation of Bacitracin Phase 2
Completed NCT03902392 - Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis N/A