The Effects of Dupilumab on Allergic Contact Dermatitis

  • STATUS
    Recruiting
  • End date
    May 18, 2023
  • participants needed
    20
  • sponsor
    Brigham and Women's Hospital
Updated on 1 March 2022
allergen
patch test
allergic contact dermatitis
triamcinolone acetonide ointment

Summary

The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.

Description

The investigators will recruit 20 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 6 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.

Details
Condition Allergic Contact Dermatitis
Treatment Dupilumab
Clinical Study IdentifierNCT03935971
SponsorBrigham and Women's Hospital
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 6 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

Exclusion Criteria

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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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