Phase
Condition
Allergy
Rosacea
Eczema (Atopic Dermatitis - Pediatric)
Treatment
Dupilumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least 18 years of age
At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmedby patch testing within 6 months of the baseline visit that can be duplicated at theinitiation 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 whohave expertise in allergic contact dermatitis
Investigator's global assessment score of at least 3 (range 0-4) at the screeningand baseline visits
Documented recent history (within 18 months of patch testing) of inadequate responseto treatment with topical medications and allergen avoidance
Able and willing to provide informed consent, participate in study visits, andundergo visit procedures
Exclusion
Exclusion Criteria:
Prior dupilumab use
Treatment with a systemic immune-regulating medication within 3 months of thebaseline visit or the patient's prior patch testing, whichever is longer. Examplesof these medications include azathioprine, methotrexate, mycophenolate mofetil,Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporineor 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 thepatient's prior patch testing, whichever is longer.
Use of rituximab within at 6 months (or until lymphocyte counts have normalized iflonger 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 1week before the baseline visit
Other active conditions, such as psoriasis, that may confound clinical evaluationsof dermatitis and patient-reported symptoms
Increased risk of infection or reactivated infection, including history of humanimmunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receiptof a live attenuated vaccine within 3 months of the baseline visit, chronic or acuteinfection requiring treatment within 4 weeks of the baseline visit, immunosuppressedstatus (ie recurrent or resistant opportunistic infections)
Malignancy within 5 years of the screening visit excluding local cutaneous squamouscell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has beenfully treated.
Women who are or plan to become pregnant or breastfeed during study participation orare unable or not willing to use birth control during the study and for 4 monthsafter the last dose of dupilumab. Options for birth control include abstinence,double barrier (ie male condom and female diaphragm), vasectomy, intrauterinedevice, and hormonal contraception. Females who have not had menses within 1 year ofthe baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomyvisit do not require additional methods contraception during study participation.
Unstable condition or status, as per study investigator's judgment, that may lead tomore likely discontinuation from the study including but not limited to major,recurrent medical illnesses that may require hospital admission and/ordiscontinuation of dupilumab, surgery that would require discontinuation ofdupilumab and/or major rehabilitation, inability to participate in all study visitsand administer dupilumab
Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maineor Vermont state.
Unable to use Zoom videoconferencing.
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital, Department of Dermatology
Boston, Massachusetts 02115
United StatesSite Not Available
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