Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
NCT ID: NCT05535738
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2022-11-15
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This IRB protocol will use select FDA-approved, commercially available biologic drugs and topical steroids that have good safety profiles and block inflammatory signals that we observed in our previously acquired data of contact dermatitis.
This study will provide insight into human immunology that will deepen our understanding of dermatologic disease, as well as increase our understanding of topical steroids and biologic treatments which sometimes cause paradoxical inflammation despite being designed to suppress inflammation. We hope this will improve the basic understanding of human skin inflammation in order to ultimately impact treatment strategies for several skin diseases.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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%}
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
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
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.
Skin punch biopsy
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
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.
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%}
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
Dupilumab
300mg
Adalimumab
40mg
Ustekinumab
45mg
Guselkumab
100mg
Canakinumab
150mg
Sarilumab
200mg
Triamcinolone Acetonide
0.1% ointment
Betamethasone Valerate
0.1% ointment
Fluticasone Propionate
0.005% ointment
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
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.
Skin punch biopsy
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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%}
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
Dupilumab
300mg
Adalimumab
40mg
Ustekinumab
45mg
Guselkumab
100mg
Canakinumab
150mg
Sarilumab
200mg
Triamcinolone Acetonide
0.1% ointment
Betamethasone Valerate
0.1% ointment
Fluticasone Propionate
0.005% ointment
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
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.
Skin punch biopsy
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wei-Che Ko
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wei-Che Ko
Professor of Dermatology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wei-Che Ko, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wei-Che Ko, MD
Role: primary
Isaac (Li-Chi) Chen, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00000321
Identifier Type: -
Identifier Source: org_study_id