Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Running, not enrolling · Phase 2/Phase 3
Conditions studied: Skin Inflammation, Allergic Contact Dermatitis
In brief
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.
Key facts
- Study ID
- NCT05535738
- Run by
- Wei-Che Ko
- People needed
- 45
- Starts
- 2022-11-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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