UMIN-CTR Clinical Trial

Basic information
Public title	Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Acronym	Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Scientific Title	Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Scientific Title:Acronym	Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Region	Japan

Condition
Condition	atopic dermatitis, seborrheic dermatitis and asteatotic eczema with symptoms on the face
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigated the safety and usefulness of transparent solid soaps in patients with mild to moderate atopic dermatitis and seborrheic dermatitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	safety and usefulness
Key secondary outcomes	Subject background Usage log Subject questionnaire

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Subjects use test facial soap instead of regular soap for four weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with skin diseases described in Condition 2.Japanese over 20 years old when obtaining consent 3.On participation in this study, Patients who have been given sufficient explanations, have gotten their full understanding and written consent. 4.Outpatient 5.Patients who is deemed appropriate by the Research Responsibility (charge) doctor.
Key exclusion criteria	1.Patients with skin diseases described in without Condition 2.Patients have inappropriate eczema (emarkable Erythema or erosion, etc...) 3.Patients have an allergy in ingredient of test soap. 4.Pregnant or possibly pregnant woman 5.Patients who is deemed inappropriate by the Research Responsibility (charge) doctor.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Funasaka
Organization	Nippon Medical School
Division name	Dermatology
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	0338222131
Email	funasaka@nms.ac.jp

Public contact
Name of contact person	1st name Hidehisa Middle name Last name Saeki
Organization	Nippon medical school hospital
Division name	Dermatology
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	0338222131
Homepage URL
Email	h-saeki@nms.ac.jp

Sponsor
Institute	Nippon medical school hospital
Institute
Department

Funding Source
Organization	MOCHIDA HEALTHCARE CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Takano Medical Clinic.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Hospital IRB
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	0338222131
Email	clinicaltrial@nms.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 25 Day
Date of IRB	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 04 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 28 Day
Last modified on	2020 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045200