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โ† Trials
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Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis

RecruitingPhase 4Ages 6 Years - 17 YearsAllNorthwestern University
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In plain words

What the trial is, and whether it could suit you

Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants, 6-17 years old at time of enrollment. * Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist. * AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4). * Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score โ‰ฅ60. * Willing and able to comply with visits and study-related procedures. * On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines. Exclusion Criteria: * Poorly controlled asthma (Asthma Control Test โ‰ค19). * Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis. * Use of concomitant medication that causes scratching. * Major medical condition (such as cancer). * Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives (urticaria). * Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment). * Use of systemic immunosuppressant within 30 days of first PSG. * Having showered or used moisturizers within 12 hours of first or second PSG. * Unable to communicate in English (some PROMIS questionnaires not available in translation). * Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components). * Pregnancy. * Clinical blindness (circadian disturbing).
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What it tests

  • Dupilumab
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Where

1 site
Lurie Children's Hospital/Northwestern University
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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