臨床研究等提出・公開システム

Date of registration	April. 16, 2023
Last modified on	Oct. 04, 2023
Trial ID	jRCT1040230009

Scientific Title	Skin care to overcome Atopic dermatitis in acute phase (SOAP study)
Public Title	SOAP study (SOAP study)

Contact for Scientific Queries	Name	Inuzuka Yusuke
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan
	Telephone	+81-53-435-2111
	E-mail	inuzuka-y@hama-med.ac.jp
Contact for Public Queries	Name	Inuzuka Yusuke
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan
	Telephone	+81-53-435-2111
	E-mail	inuzuka-y@hama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 16, 2023
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	No limit
	Age Maximum	15age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atopic dermatitis
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.
Health Condition(s) Keyword		Atopic dermatitis
Health Condition(s) Code		D003876
Primary Outcome(s)		Percentage of achievement of EASI100 excluding head and neck at the end of the study
Secondary Outcome(s)		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)

Primary Sponsor	Inuzuka Yusuke

Secondary Sponsor

Source of Monetary Support	Maruho Medical, Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu City , 431- 3192 Japan, Shizuoka
Telephone	+81-53-435-2111
E-Mail	rinri@hama-med.ac.jp
Approval Status	Approval
Date of approval	Jan. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 04, 2023	(this page)	Changes
1	April. 16, 2023	Detail

List of change history