The Effects of Dupilumab on Allergic Contact Dermatitis
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|ClinicalTrials.gov Identifier: NCT03935971|
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergic Contact Dermatitis||Drug: Dupilumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Dupilumab on Allergic Contact Dermatitis|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Subjects with Allergic Contact Dermatitis
Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks
See arm/group description
- Change 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
- Change in Body Surface Area (BSA) [ Time Frame: week 0, week 6, week 12 ]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.
- Change in Eczema Area and Severity Index (EASI) score [ Time Frame: week 0, week 6, week 12 ]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).
- Change in Numerical Rating Scale (NRS) itch [ Time Frame: week 0, week 6, week 12 ]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.
- Change in Dermatology Life Quality Index (DLQI) [ Time Frame: week 0, week 6, week 12 ]The Dermatology Life Quality Index is a 10-question, patient-reported instrument to assess impact of skin diseases on patient quality of life.
- Change in SLEEPY-Q (Sleep Questionnaire) score [ Time Frame: week 0, week 6, week 12 ]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).
- Skin Samples [ Time Frame: week0+72-120 hours and week 12+72-120 hours ]Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the skin of patients will be evaluated before and after dupilumab.
- Blood Samples [ Time Frame: week 0, week0+72-120 hours, week 12 and week 12+72-120 hours ]Inflammatory markers (Th1, Th2, Th17, Th22 immune pathways) in the blood of patients will be evaluated before and after dupilumab.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935971
|Contact: Liset Chacin, BAfirstname.lastname@example.org|