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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 15, 2022

Primary Completion Date

January 1, 2027

Study Completion Date

December 31, 2027

Conditions
Skin InflammationAllergic 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.

Trial Locations (1)

01605

RECRUITING

University of Massachusetts Chan Medical School, Worcester

All Listed Sponsors
lead

John Harris

OTHER