A contact dermatitis model with biologic medications to study skin inflammation through suction blistering

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The purpose of this clinical research is to study mechanisms of human skin inflammation by using an established model of transient contact dermatitis with pre-treatment by biologic drugs that block specific inflammatory signals or by topical steroids that block broad inflammatory signals.

Contact dermatitis will be induced in a safe and controlled manner through the use of topical application of squaric acid dibutyl ester (SADBE), along with other common allergens, after which skin will be sampled for analysis using nonscarring skin biopsy techniques including suction blister biopsies and/or application of absorptive microneedle patches.

This IRB protocol will use select FDA-approved, commercially available biologic drugs and topical steroids that have good safety profiles and block inflammatory signals that we observed in our previously acquired data of contact dermatitis. This study will provide insight into human immunology that will deepen our understanding of dermatologic disease, as well as increase our understanding of topical steroids and biologic treatments which sometimes cause paradoxical inflammation despite being designed to suppress inflammation. We hope this will improve the basic understanding of human skin inflammation in order to ultimately impact treatment strategies for several skin diseases.

The clinical trial starts in September 15, 2022 and will continue throughout December 31, 2027 at the University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States.

The study enrolls healthy adult subjects over the age of 18 years with no skin diseases, as well as patients with dermatologic conditions such as atopic dermatitis, history of localized non-melanoma, keratinocytic skin cancer, and patients with previous clinical patch testing. For the complete list of the criteris please visit: https://ichgcp.net/clinical-trials-registry/NCT05535738.

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