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Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Sponsor: Wei-Che Ko
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.
Official title: Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2022-11-15
Completion Date
2027-12-31
Last Updated
2025-11-14
Healthy Volunteers
Yes
Interventions
Squaric Acid Dibutyl Ester
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%}
Known patch test allergens
Positive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling
Dupilumab
300mg
Adalimumab
40mg
Ustekinumab
45mg
Guselkumab
100mg
Canakinumab
150mg
Sarilumab
200mg
Triamcinolone Acetonide
0.1% ointment
Betamethasone Valerate
0.1% ointment
Fluticasone Propionate
0.005% ointment
Microneedle
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
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.
Skin punch biopsy
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
Locations (1)
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States