Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 14, 2025
May 1, 2025
4.1 years
September 6, 2022
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)
Baseline and after pre-treatment with immunomodulating medication
Up to 5 years
Secondary Outcomes (1)
Correlation of protein biomarkers collected by microneedles
Up to 5 years
Study Arms (2)
Baseline Contact Allergen
EXPERIMENTALIndividuals 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.
Contact Allergen with Immunomodulator Pre-Treatment
EXPERIMENTALIndividuals 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.
Interventions
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%}
Positive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling
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 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.
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Adults unable to give consent
- History of the following specific dermatologic conditions (which would be confounders due to their particular immunologic etiologies, specifically the TNFa and IL-17 pathways which oppose the Th2 pathway): pityriasis rubra pilaris and psoriasis
- Patients actively receiving whole body phototherapy
- Patients actively receiving systemic broad-spectrum immunosuppression (prednisone, mycophenolate mofetil, azathioprine, methotrexate)
- Any history of poor wound healing
- History of uncontrolled diabetes
- History of easily torn skin
- Any known cardiac arrhythmia or history of heart failure
- History of demyelinating disease
- History of liver disease or alcohol abuse
- History of melanoma
- Pregnant women
- Individuals who are high risk for tuberculosis including prisoners, immigrants from TB- endemic areas, or US-based travelers who have visited TB-endemic areas
- Individuals with a self-reported personal history of infection with latent or active tuberculosis, HIV, Hepatitis B, or Hepatitis C will not be included, because the type of immunotherapies that will be used in this study may interfere with these conditions.
- For similar reasons, we will not be including individuals with signs of current or active infection, self-reported personal history of recurrent infections, or conditions that compromise the immune system, such as patients with malignancy (except non- melanoma, keratinocytic skin cancers).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wei-Che Kolead
Study Sites (1)
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei-Che Ko, MD
University of Massachusetts Chan Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Dermatology
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 10, 2022
Study Start
November 15, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 14, 2025
Record last verified: 2025-05