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RecruitingAtopic DermatitisSleep Disturbance

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

Eligible age

6–17 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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

Sponsor: Northwestern University

You may qualify if…

  • ✓ 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 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.

You may not qualify if…

  • ✕ Poorly controlled asthma (Asthma Control Test ≤19).
  • ✕ 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.

Where it's recruiting

Illinois

Chicago

Source: ClinicalTrials.gov · NCT05042258 · last updated 2026-04-27

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