JPRN-UMIN000024665Not yet recruiting未知
Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device
estle Skin Health S.A.0 sites35 target enrollmentStarted: November 18, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1) The subject with a diagnosis of atopic dermatitis based on 'Definition and diagnostic criteria for atopic dermatitis' by the Japanese Dermatological Association
- •2) The subject aged >= 20 years at the time of informed consent.
- •3) The moderate to severe atopic dermatitis patients with > score 7 in Eczema Area and Severity Index (EASI).
- •4) The subject with mean itch score >= 5 in Numerical Rating Scale (NRS) during 7 days before the measurement. Itch intensity is self-measured on a 10-pt numerical scale, where 0 = no itch and 10 = worst possible itch.
- •5) The subject with itch score >= 5 in NRS on the measurement day.
- •6) The subject without change in treatment including atopic dermatitis during 7 days before the measurement.
- •7) The subject usually takes >= 4 hours of nocturnal sleep.
- •8) The subject gives informed consent in writing for the participation in this study including video shooting of nocturnal sleep.
- •Atopic dermatitis patients
- •1) The subject with a diagnosis of atopic dermatitis based on 'Definition and diagnostic criteria for atopic dermatitis' by the Japanese Dermatological Association.
- •2) The subject aged >= 20 years at the time of informed consent.
- •3) The subject without change in treatment including atopic dermatitis during 7 days before the measurement.
- •4) The subject gives informed consent in writing for the participation in this study.
- •Healthy Adults
- •1) The subject aged >= 20 years at the time of informed consent.
- •2) The subject who is assessed as healthy by the principal investigator or subinvestigators.
- •3) The subject with mean itch score 0 in NRS during 7 days before the measurement. Short-time mild itch induced by external stimulus is not assessed as significant.
- •4) The subject with itch score 0 in NRS on the measurement day. Short-time mild itch induced by external stimulus is not assessed as significant.
- •5) The subject gives informed consent in writing for the participation in this study.
Exclusion Criteria
- •1) The subject has difficulty in making a decision by dementia or something.
- •2) The subject has a past medical history of disturbance of consciousness.
- •3) The subject is addicted to drug or alcohol.
- •4) The subject takes psychoactive drugs or meets indication for treatment of those drugs.
- •5) The subject has a serious complication of hepatic, renal, cardiac, hematological, endocrine, metabolic, pulmonary, or gastrointestinal disease.
- •6) Others who are assessed ineligible for this study by the principal investigator or subinvestigators.
- •1) The subject has difficulty in making a decision by dementia or something.
- •2) The subject has a past medical history of disturbance of consciousness.
- •3) The subject is addicted to drug or alcohol.
- •4) The subject takes psychoactive drugs or meets indication for treatment of those drugs.
- •5) The subject has a serious complication of hepatic, renal, cardiac, hematological, endocrine, metabolic, pulmonary, or gastrointestinal disease.
- •6) Others who are assessed ineligible for this study by the principal investigator or subinvestigators.
Investigators
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