Allergic Contact Dermatitis Clinical Trial
Official title:
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
The purpose of this study is to answer: how do inflammation and anti-inflammatory skin therapies work in the skin? Inflammation is a protective response from the body's immune system to injury, disease, or irritation. It is a process by which your body's white blood cells and the things they make protect you from infection from outside invaders such as bacteria and viruses.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 31, 2027 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy adult subjects over the age of 18 years with no skin diseases - Patients with dermatologic conditions such as atopic dermatitis, history of localized non-melanoma, keratinocytic skin cancer - Patients with previous clinical patch testing - UMass Medical School students and employees are eligible to participate. - Non-English-speaking individuals are also eligible with the assistance of an interpreter and an approved short form consent in the appropriate language. Exclusion Criteria: - Adults unable to give consent - History of the following specific dermatologic conditions (which would be confounders due to their particular immunologic etiologies, specifically the TNFa and IL-17 pathways which oppose the Th2 pathway): pityriasis rubra pilaris and psoriasis - Patients actively receiving whole body phototherapy - Patients actively receiving systemic broad-spectrum immunosuppression (prednisone, mycophenolate mofetil, azathioprine, methotrexate) - Any history of poor wound healing - History of uncontrolled diabetes - History of easily torn skin - Any known cardiac arrhythmia or history of heart failure - History of demyelinating disease - History of liver disease or alcohol abuse - History of melanoma - Pregnant women - Individuals who are high risk for tuberculosis including prisoners, immigrants from TB- endemic areas, or US-based travelers who have visited TB-endemic areas - Individuals with a self-reported personal history of infection with latent or active tuberculosis, HIV, Hepatitis B, or Hepatitis C will not be included, because the type of immunotherapies that will be used in this study may interfere with these conditions. - For similar reasons, we will not be including individuals with signs of current or active infection, self-reported personal history of recurrent infections, or conditions that compromise the immune system, such as patients with malignancy (except non- melanoma, keratinocytic skin cancers). |
Country | Name | City | State |
---|---|---|---|
United States | University of Massachusetts Chan Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
John Harris |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq) | Baseline and after pre-treatment with immunomodulating medication | Up to 5 years | |
Secondary | Correlation of protein biomarkers collected by microneedles | Correlation to RNA and/or protein expression collected by single-cell multiomics | Up to 5 years |
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