Observational Analytical Validation Study of the Replior ScratchSense

Korábbi kezelés

• Recent changes in anti-pruritic treatment: Initiation or dose changes of systemic medications that may suppress nocturnal itch within the past 2 weeks, including: i. Oral corticosteroids ii. Immunosuppressive agents (e.g., cyclosporine, methotrexate) iii. Biologics (e.g., dupilumab) unless on a stable dose ≥8 weeks iv. Sedating antihistamines unless stable for ≥1 week.
• Topical treatment use: initiation of topical corticosteroids, calcineurin inhibitors, or emollients within 3 days prior to study start, and no use during the study.

Más betegség

• No current or expected nocturnal itch: well-controlled conditions or no recent reports of nighttime scratching.
• Confounding movement disorders or sleep conditions: diagnosed restless legs syndrome, periodic limb movement disorder, moderate/severe obstructive sleep apnea, Parkinson's disease, or other conditions that may interfere with motion analysis.
• Severe psychiatric or cognitive impairment that could impair the ability to consent or comply with the protocol

• Male / female participant, aged 18 to 65 years inclusive. Negative pregnancy test at screening for childbearing potential women. Presence of itch-related and/or scratching-inducing conditions: documented or self-reported history of nocturnal itching and scratching, due to conditions such as:
  • Atopic dermatitis
  • Chronic pruritus of unknown origin
  • Other pruritic dermatological or systemic conditions. Expected Nocturnal Scratch activity: participants must: Have experienced Nocturnal Scratching in the past 7 days, and
  • Be considered likely to scratch during the study period, based on medical history, clinician judgment, or recent self-report