Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

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.

Conditions

• Skin Inflammation
• Allergic Contact Dermatitis

Interventions

DRUG

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%}

OTHER

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

DRUG

Dupilumab

300mg

DRUG

Adalimumab

40mg

DRUG

Ustekinumab

45mg

DRUG

Guselkumab

100mg

DRUG

Canakinumab

150mg

DRUG

Sarilumab

200mg

DRUG

Triamcinolone Acetonide

0.1% ointment

DRUG

Betamethasone Valerate

0.1% ointment

DRUG

Fluticasone Propionate

0.005% ointment

DEVICE

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

DEVICE

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.

PROCEDURE

Skin punch biopsy

A skin biopsy is the removal of a small piece of tissue, under local anesthetic.

Sponsors & Collaborators

• Wei-Che Ko

  lead OTHER

Principal Investigators

• Wei-Che Ko, MD · University of Massachusetts, Worcester

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-15

Primary Completion

2027-01-01

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations