Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Northwestern University
Summary
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
Description
Subjects will complete two overnight sleep studies, before and after using dupilumab for 12 weeks, to assess the effect of dupilumab on sleep disturbance in eczema patients. These overnight visits will include PSG, blood draws, skin sensors, urine collection, tape stripping, and photography. Subjects will be given dupilumab to use for 12 weeks at home before returning for the second sleep study.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
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 ≥60. * Willing and able to comply with visits and study-related procedures. * On stable regimens (consistent use 14 days before Day…
Interventions
- DrugDupilumab
12 week dupilumab administration
Location
- Lurie Children's Hospital/Northwestern UniversityChicago, Illinois