MedPath

SOAP study

Phase 2
Recruiting
Conditions
D003876
Atopic dermatitis
Registration Number
JPRN-jRCT1040230009
Lead Sponsor
Inuzuka Yusuke
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Patients diagnosed with AD based on the UK Working Partys Diagnostic Criteria
Patients aged younger than 15 years old at recruitment
Patients whose eczema excluding the head, neck, wrists/ankles, and genitals are mild to severe
Patients who bathe or shower at least once a day
Patients whose caregivers agreed to participate in this study in writing

Exclusion Criteria

1. Patients with skin infection
2. Patients who apply steroid ointment, antihistamine ointment (oral is allowed), NSAIDs ointment, tacrolimus ointment, dergocitinib ointment, and difamilast ointment for diseases other than atopic dermatitis. (It is possible to apply to areas other than the intervention site.)
3. Patients taking cyclosporine, corticosteroids, baricitinib, upadacitinib, or abrocitinib
4. Patients receiving dupilumab or nemolizumab
5. Physicians decide that the patients is not appropriate for participation in the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of achievement of EASI100 excluding head and neck at the end of the study
Secondary Outcome Measures
NameTimeMethod
EASI score excluding head and neck at the end of the study<br>POEM score at the end of the study<br>Stratum corneum hydration of the forearm at the end of the study<br>Number of occurrences of serious adverse events<br>Adverse events for which a causal relationship to the intervention cannot be denied<br>Presence or absence of contagious impetigo<br>Presence or absence of skin infections other than contagious impetigo<br>Pain during bathing (10-step scale)
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