Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Device, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Contact Information
Primary
Celia Hartigan, RN
celia.hartigan@umassmed.edu
774-455-4758
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 45
Treatments
Experimental: Baseline Contact Allergen
Individuals who will have allergic contact dermatitis induced via squaric acid dibutyl ester (SADBE) and/or known patch test allergens followed by skin and blood sampling. There is a protocol to sensitize individuals to SADBE if they have not previously been exposed to SADBE.
Experimental: Contact Allergen with Immunomodulator Pre-Treatment
Individuals from Arm 1 (Baseline Contact Allergen) who have been exposed to SADBE and/or known patch test allergens followed by skin and blood sampling. These individuals will be pre-treated via administration of a single dose of 1 biologic from the following list: dupilumab, adalimumab, ustekinumab, guselkumab, canakinumab, sarilumab; or a single application of 1 topical steroid from the following list: betamethasone valerate, triamcinolone acetonide, fluticasone propionate. Allergic contact dermatitis will then be induced and the skin sampled.
Related Therapeutic Areas
Sponsors
Leads: John Harris

This content was sourced from clinicaltrials.gov