Skin InflammationPhase 2/3NCT05535738
Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
A Phase 2/3 study testing Squaric Acid Dibutyl Ester, Known patch test allergens and Dupilumab in people with Skin Inflammation and Allergic Contact Dermatitis, run by Wei-Che Ko at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation, Allergic Contact Dermatitis
- What is being tested?
- Squaric Acid Dibutyl Ester, Known patch test allergens and Dupilumab
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
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.
Read the detailed description
The purpose of this study is to study mechanisms of human skin inflammation by using an established model of transient contact dermatitis with pre-treatment by biologic drugs that block specific inflammatory signals or by topical steroids that block broad inflammatory signals. Contact dermatitis will be induced in a safe and controlled manner through the use of topical application of squaric acid dibutyl ester (SADBE), along with other common allergens, after which skin will be sampled for analysis using nonscarring skin biopsy techniques including suction blister biopsies and/or application of absorptive microneedle patches.
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
- Skin Inflammation, Allergic Contact Dermatitis
- Being tested
- Squaric Acid Dibutyl Ester, Known patch test allergens, Dupilumab, Adalimumab, Ustekinumab
- Keywords
- skin inflammation, allergic contact dermatitis
- Medical subject headings
- Dermatitis, Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squaric Acid Dibutyl EsterDrug
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 allergensOther
Positive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling
DupilumabDrug
300mg
AdalimumabDrug
40mg
UstekinumabDrug
45mg
GuselkumabDrug
100mg
CanakinumabDrug
150mg
SarilumabDrug
200mg
Triamcinolone AcetonideDrug
0.1% ointment
Betamethasone ValerateDrug
0.1% ointment
Fluticasone PropionateDrug
0.005% ointment
MicroneedleDevice
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 blisteringDevice
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 biopsyProcedure or surgery
A skin biopsy is the removal of a small piece of tissue, under local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Contact Allergen | Experimental | 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. Receives: Drug: Squaric Acid Dibutyl Ester; Other: Known patch test allergens; Device: Microneedle; Device: Suction blistering; Procedure: Skin punch biopsy |
| Contact Allergen with Immunomodulator Pre-Treatment | Experimental | 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. Receives: Drug: Squaric Acid Dibutyl Ester; Other: Known patch test allergens; Drug: Dupilumab; Drug: Adalimumab; Drug: Ustekinumab; Drug: Guselkumab; Drug: Canakinumab; Drug: Sarilumab; Drug: Triamcinolone Acetonide; Drug: Betamethasone Valerate; Drug: Fluticasone Propionate; Device: Microneedle; Device: Suction blistering; Procedure: Skin punch biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)
Baseline and after pre-treatment with immunomodulating medication
Measured: Up to 5 years
Secondary outcomes (1)
Correlation of protein biomarkers collected by microneedles
Correlation to RNA and/or protein expression collected by single-cell multiomics
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start15 Nov 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- There are two phases in this study. The first phase involves sensitization to a contact allergen and skin sampling to establish baseline characteristics. In the second phase, the participant will be pre-treated with a one time dose of an immunomodulating medication, re-treated with a contact allergen, followed by skin sampling.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei-Che Ko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei-Che Ko, University of Massachusetts, Worcester
- Investigators
- Wei-Che Ko, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535738
- Sponsor's protocol ID
- STUDY00000321
- Status last verified
- May 2026
- First submitted
- 6 Sep 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologics and Blistering - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Through Suction Blistering
- ClinicalTrials.gov ID
- NCT05535738
- Acronym / sponsor ID
- STUDY00000321
- Conditions
- Skin Inflammation, Allergic Contact Dermatitis
- Keywords
- skin inflammation, allergic contact dermatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Wei-Che KoUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to study mechanisms of human skin inflammation by using an established model of transient contact dermatitis with pre-treatment by biologic drugs that block specific inflammatory signals or by topical steroids that block broad inflammatory signals. Contact dermatitis will be induced in a safe and controlled manner through the use of topical application of squaric acid dibutyl ester (SADBE), along with other common allergens, after which skin will be sampled for analysis using nonscarring skin biopsy techniques including suction blister biopsies and/or application of absorptive microneedle patches.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two phases in this study. The first phase involves sensitization to a contact allergen and skin sampling to establish baseline characteristics. In the second phase, the participant will be pre-treated with a one time dose of an immunomodulating medication, re-treated with a contact allergen, followed by skin sampling.
| Arm | Type | Receives |
|---|---|---|
| Baseline Contact Allergen | Experimental | Drug: Squaric Acid Dibutyl Ester, Other: Known patch test allergens, Device: Microneedle, Device: Suction blistering, Procedure: Skin punch biopsyIndividuals 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 | Experimental | Drug: Squaric Acid Dibutyl Ester, Other: Known patch test allergens, Drug: Dupilumab, Drug: Adalimumab, Drug: Ustekinumab, Drug: Guselkumab, Drug: Canakinumab, Drug: Sarilumab, Drug: Triamcinolone Acetonide, Drug: Betamethasone Valerate, Drug: Fluticasone Propionate, Device: Microneedle, Device: Suction blistering, Procedure: Skin punch biopsyIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squaric Acid Dibutyl EsterSensitization 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%} | Drug | Baseline Contact Allergen, Contact Allergen with Immunomodulator Pre-Treatment |
| Known patch test allergensPositive patch test allergens during the course of clinical patch testing will be re-applied on the back followed by skin sampling | Other | Baseline Contact Allergen, Contact Allergen with Immunomodulator Pre-Treatment |
| Dupilumab300mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Adalimumab40mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Ustekinumab45mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Guselkumab100mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Canakinumab150mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Sarilumab200mg | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Triamcinolone Acetonide0.1% ointment | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Betamethasone Valerate0.1% ointment | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| Fluticasone Propionate0.005% ointment | Drug | Contact Allergen with Immunomodulator Pre-Treatment |
| MicroneedlePainless 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 | Baseline Contact Allergen, Contact Allergen with Immunomodulator Pre-Treatment |
| Suction blisteringSuction 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. | Device | Baseline Contact Allergen, Contact Allergen with Immunomodulator Pre-Treatment |
| Skin punch biopsyA skin biopsy is the removal of a small piece of tissue, under local anesthetic. | Procedure or surgery | Baseline Contact Allergen, Contact Allergen with Immunomodulator Pre-Treatment |
Primary outcome
To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)
Time frame: Up to 5 years
Baseline and after pre-treatment with immunomodulating medication
1 secondary outcome
Correlation of protein biomarkers collected by microneedles
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Che Ko, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Squaric Acid Dibutyl Ester, Known patch test allergens and Dupilumab in people with Skin Inflammation and Allergic Contact Dermatitis, run by Wei-Che Ko at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.