Exploring skin inflammation and treatments using a contact dermatitis model
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
This study tests how well biologic medications and topical steroids can reduce skin inflammation caused by contact dermatitis in healthy adults.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Drugs / interventions | methotrexate, prednisone |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT05535738 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the mechanisms of skin inflammation by inducing contact dermatitis in healthy adults using a controlled application of allergens. Participants will receive biologic medications or topical steroids to observe their effects on inflammation. Skin samples will be collected through non-invasive techniques for analysis. The research seeks to enhance understanding of how these treatments work and their potential paradoxical effects on inflammation.
Who should consider this trial
Good fit: Ideal candidates include healthy adults over 18 years old, as well as those with certain dermatologic conditions like atopic dermatitis.
Not a fit: Patients with specific dermatologic conditions such as psoriasis or those receiving systemic immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for various skin diseases by enhancing our understanding of skin inflammation and the effects of biologic therapies.
How similar studies have performed: Other studies have shown success in using similar models to understand skin inflammation, but this specific approach with biologics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Worcester, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Wei-Che Ko, MD — University of Massachusetts, Worcester
- Study coordinator: Wei-Che Ko, MD
- Email: Wei-Che.Ko@umassmed.edu
- Phone: 508-856-1706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.