The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
See arm/group description
Brigham and Women's Hospital, Department of Dermatology
Boston, Massachusetts, United States
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.
Time frame: week 0, week 6, week 12
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: week 0, week 6, week 12
Change in SLEEPY-Q (Sleep Questionnaire) Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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.
Time frame: 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.
Time frame: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours