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

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
Wei-Che Ko
Study ID
NCT05535738
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Allergic Contact Dermatitis
  • Skin Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Squaric Acid Dibutyl Ester — DRUG
    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 — OTHER
    Positive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling
  • Dupilumab — DRUG
    300mg
  • Adalimumab — DRUG
    40mg
  • Ustekinumab — DRUG
    45mg
  • Guselkumab — DRUG
    100mg
  • Canakinumab — DRUG
    150mg
  • Sarilumab — DRUG
    200mg
  • Triamcinolone Acetonide — DRUG
    0.1% ointment
  • Betamethasone Valerate — DRUG
    0.1% ointment
  • Fluticasone Propionate — DRUG
    0.005% ointment
  • Microneedle — DEVICE
    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 — DEVICE
    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 — PROCEDURE
    A skin biopsy is the removal of a small piece of tissue, under local anesthetic.

Study Details

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.

Key Dates

Start date
Nov 15, 2022
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq) [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01605-

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By research site
University of Massachusetts Chan Medical School· Worcester, MA

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