SOAP study

JRCT ID: jRCT1040230009

Registered date:16/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 16/04/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Participants in the Soap group wash their skin with soap when bathing or showering for 7-14 days.
Participants in the Mild-Soap group wash their skin with Mild-Soap when bathing or showering for 7-14 days.
Participants in the water group wash their skin with only hot water when bathing or showering for 7-14 days.
The scalp, face, distal to the wrist/ankle, and pubic area are not intervention sites.

Outcome(s)

• Primary Outcome: Percentage of achievement of EASI100 excluding head and neck at the end of the study

Secondary Outcome

EASI score excluding head and neck at the end of the study
POEM score at the end of the study
Stratum corneum hydration of the forearm at the end of the study
Number of occurrences of serious adverse events
Adverse events for which a causal relationship to the intervention cannot be denied
Presence or absence of contagious impetigo
Presence or absence of skin infections other than contagious impetigo
Pain during bathing (10-step scale)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 15age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Inuzuka Yusuke
• Source(s) of Monetary Support: Maruho Medical, Inc.