Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
Wei-Che Ko
45 participants
Nov 15, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria15
- 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).
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Interventions
Sensitization dose: 2% Elicitation doses: {0.0001%, 0.00025%, 0.00075%, 0.001%, 0.0025%, 0.005%, 0.0075%, 0.01%, 0.025%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6% 0.7%, 0.8%, 0.9%, 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2.0%}
Positive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling
300mg
40mg
45mg
100mg
150mg
200mg
0.1% ointment
0.1% ointment
0.005% ointment
Painless and non-scarring skin sampling with a 7mm x 7mm patch of hydrogel-coated poly-l-lactide microneedles (\<2mm length) will be used to collect interstitial fluid
Suction blistering is a technique to induce and collect blister fluid using a negative pressure instrument (Electronic Diversities Finksburg, MD). It does not require local anesthetic, stitches or pain medication following the procedure. The blisters will be no greater than 1cm in diameter and no deeper than the epidermis (\<1mm deep). This process of inducing blisters is typically less than 1 hour. After the formation of blisters, the blister fluid will be extracted using a syringe. The blister roofs will be left attached to the skin and covered with petrolatum and a bandage.
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05535738