Assessment of nocturnal scratching activity in atopic dermatitis patients with scratching-detecting device

Not Applicable

• Conditions: Atopic dermatitis

• Registration Number: JPRN-UMIN000024665
• Lead Sponsor: estle Skin Health S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Step 1
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.

Step 2
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

Step 1
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.

Step 2
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Step 1<br>?Overall evaluation the performance of the scratching-detecting device including sensitivity, specificity, and positive predictive value<br>?Adverse events / adverse drug reactions<br><br>Step 2<br>?Comparison of accumulative time of nocturnal scratching activity between atopic dermatitis patients and healthy adults<br>?Correlation of nocturnal scratching activity with intensity of atopic dermatitis and with intensity of self-evaluated itch and sleep disturbance<br>?Adverse events / adverse drug reactions