Allergic Contact DermatitisPhase 4NCT03935971
The Effects of Dupilumab on Allergic Contact Dermatitis
A Phase 4 study testing Dupilumab in people with Allergic Contact Dermatitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmed by patch testing within 6 months of the baseline visit that can be duplicated at the initiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours).
- Allergic contact dermatitis diagnosed clinically by the principle investigators who have expertise in allergic contact dermatitis
- Investigator's global assessment score of at least 3 (range 0-4) at the screening and baseline visits
- Documented recent history (within 18 months of patch testing) of inadequate response to treatment with topical medications and allergen avoidance
- Able and willing to provide informed consent, participate in study visits, and undergo visit procedures
Who cannot join
- Prior dupilumab use
- Treatment with a systemic immune-regulating medication within 3 months of the baseline visit or the patient's prior patch testing, whichever is longer. Examples of these medications include azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporine or prednisone may not have been used within 1 month of the baseline visit.
- Treatment with other biologic agents, such as TNF inhibitors, anti-IL 17 agents, anti-IL 12/23 agents, or anti-IL 23 agents, within 4 months of baseline visit or the patient's prior patch testing, whichever is longer.
- Use of rituximab within at 6 months (or until lymphocyte counts have normalized if longer than 6 months) of the baseline visit or the patient's prior patch testing, whichever is longer.
- Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit
- Other active conditions, such as psoriasis, that may confound clinical evaluations of dermatitis and patient-reported symptoms
Show all 12Show fewer
- Increased risk of infection or reactivated infection, including history of human immunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receipt of a live attenuated vaccine within 3 months of the baseline visit, chronic or acute infection requiring treatment within 4 weeks of the baseline visit, immunosuppressed status (ie recurrent or resistant opportunistic infections)
- Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has been fully treated.
- Women who are or plan to become pregnant or breastfeed during study participation or are unable or not willing to use birth control during the study and for 4 months after the last dose of dupilumab. Options for birth control include abstinence, double barrier (ie male condom and female diaphragm), vasectomy, intrauterine device, and hormonal contraception. Females who have not had menses within 1 year of the baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomy visit do not require additional methods contraception during study participation.
- Unstable condition or status, as per study investigator's judgment, that may lead to more likely discontinuation from the study including but not limited to major, recurrent medical illnesses that may require hospital admission and/or discontinuation of dupilumab, surgery that would require discontinuation of dupilumab and/or major rehabilitation, inability to participate in all study visits and administer dupilumab
- Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maine or Vermont state.
- Unable to use Zoom videoconferencing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital, Department of Dermatology
Boston, Massachusetts, 02115
About this study
The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
Read the detailed description
The investigators will recruit 30 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 18 months after patch testing, but where allergic contact dermatitis is still suspected. Subjects will receive 10 weeks of dupilumab, and both clinical data and tissue samples will be assessed.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Dupilumab
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Allergic Contact Dermatitis | Experimental | Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Investigator's Global Assessment (IGA) Score
The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.
Measured: week 0, week 6, week 12
Secondary outcomes (7)
Change in Body Surface Area (BSA)
The body surface area is a physician-reported measure of the amount of disease involvement. The patient's palm size approximates 1% of body surface area involvement.
Measured: week 0, week 6, week 12
Change in Eczema Area and Severity Index (EASI) Score
The eczema-area-and-severity-index score is a composite score of disease severity and extent of disease distribution. It was initially developed for evaluation of eczema. Disease severity (range 0-3; 0 being no disease and 3 being severe disease) is a measure of redness, thickness/induration, scratching, and lichenification. Each characterization is measured separately for body regions (head and neck, trunk, upper extremities, and lower extremities) to calculate a regional score. The total score is a sum of the four body regions (range 0-72).
Measured: week 0, week 6, week 12
Change in Numerical Rating Scale (NRS) Itch
The numerical rating scale for itch is a patient-reported measure of itch (range 0-10) with 0 being no itch and 10 being the worst imaginable itch.
Measured: week 0, week 6, week 12
Change in Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index is a 10-question, patient-reported instrument to assess impact of skin diseases on patient quality of life.
Measured: week 0, week 6, week 12
Change in SLEEPY-Q (Sleep Questionnaire) Score
The Sleepy-Q is a patient-derived, patient-reported sleep questionnaire for patients with chronic inflammatory dermatoses that consists of 28 individual questions. It assesses four dimensions of sleep in patients with inflammatory skin conditions: sleep disturbance (overall score 0-40, 0 being "no sleep disturbance" and 40 being "severe sleep disturbance"), causes of sleep disturbance related to dermatitis (binary, yes/no), causes of sleep disturbance unrelated to dermatitis (binary, yes/no), and impairment related to sleep disturbance (two subscales including Life Impairment Score = overall 0-40, being 0 "no life impairment" and 40 "severe life impairment" and Dermatitis Impairment Score = overall 0-30, being 0 "no impairment" and 30 "severe impairment." The total impairment related to sleep disturbance is scored overall 0-70 after summing of the two subscales).
Measured: week 0, week 6, week 12
Skin Samples
Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab.
Measured: week0+72-120 hours and week 12+72-120 hours
Blood Samples
Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab.
Measured: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start18 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic Contact DermatitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Ari Goldminz, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935971
- Sponsor's protocol ID
- 2018P002882
- Status last verified
- Feb 2026
- First submitted
- 23 Apr 2019
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dupilumab on Allergic Contact Dermatitis
- ClinicalTrials.gov ID
- NCT03935971
- Acronym / sponsor ID
- 2018P002882
- Conditions
- Allergic Contact Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
Detailed description
The investigators will recruit 30 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 18 months after patch testing, but where allergic contact dermatitis is still suspected. Subjects will receive 10 weeks of dupilumab, and both clinical data and tissue samples will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Allergic Contact Dermatitis | Experimental | Drug: DupilumabDupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmed by patch testing within 6 months of the baseline visit that can be duplicated at the initiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours).
- Allergic contact dermatitis diagnosed clinically by the principle investigators who have expertise in allergic contact dermatitis
- Investigator's global assessment score of at least 3 (range 0-4) at the screening and baseline visits
- Documented recent history (within 18 months of patch testing) of inadequate response to treatment with topical medications and allergen avoidance
Key exclusion criteria (12 listed)
- Prior dupilumab use
- Treatment with a systemic immune-regulating medication within 3 months of the baseline visit or the patient's prior patch testing, whichever is longer. Examples of these medications include azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporine or prednisone may not have been used within 1 month of the baseline visit.
- Treatment with other biologic agents, such as TNF inhibitors, anti-IL 17 agents, anti-IL 12/23 agents, or anti-IL 23 agents, within 4 months of baseline visit or the patient's prior patch testing, whichever is longer.
- Use of rituximab within at 6 months (or until lymphocyte counts have normalized if longer than 6 months) of the baseline visit or the patient's prior patch testing, whichever is longer.
- Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit
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 |
|---|---|---|
| DupilumabSee arm/group description | Drug | Subjects with Allergic Contact Dermatitis |
Primary outcome
Change From Baseline in Investigator's Global Assessment (IGA) Score
Time frame: week 0, week 6, week 12
The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.
7 secondary outcomes
Change in Body Surface Area (BSA)
Time frame: week 0, week 6, week 12
Change in Eczema Area and Severity Index (EASI) Score
Time frame: week 0, week 6, week 12
Change in Numerical Rating Scale (NRS) Itch
Time frame: week 0, week 6, week 12
Change in Dermatology Life Quality Index (DLQI)
Time frame: week 0, week 6, week 12
Change in SLEEPY-Q (Sleep Questionnaire) Score
Time frame: week 0, week 6, week 12
Skin Samples
Time frame: week0+72-120 hours and week 12+72-120 hours
Blood Samples
Time frame: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Allergic Contact Dermatitis, run by Brigham and Women's Hospital 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 6 inclusion and 12 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 16 Jul 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Investigator's Global Assessment (IGA) Score (time frame: week 0, week 6, week 12). 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 16 Jul 2026.