UMIN-CTR Clinical Trial

Basic information
Public title	Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.
Acronym	Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.
Scientific Title	Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.
Scientific Title:Acronym	Application test of a skin care medicine (cleansing agent) in patients with skin diseases such as atopic dermatitis and asteatotic dermatitis.
Region	Japan

Condition
Condition	The test participants are patients with a condition, such as atopic dermatitis or asteatotic dermatitis, who presented with symptoms of inflammation and xerosis.
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To offer a cleansing agent that can be used at ease as a skin care medicine in daily life and the appropriate directions for the patient with dermatosis with skin dryness and an inflammation such as atopic dermatitis and asteatotic dermatitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The severity of symptoms (erythema, papule, desquamation, xerosis, etc.) of the subject must not worsen, and the morphology and area of the stratum corneum (indicates the degree of cornification of the epidermal cells)
Key secondary outcomes	Skin measurements were performed by using measuring devices and analyzing the horny cell layer by using tape-stripping method. Moisture content of the epidermal horny cell layer, amount of moisture loss through the skin, cytokines in the horny cell layer

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
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	After 4 weeks of conditioning, for normal personal use, substitute the cleansing agent with the product of this study.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Progression of the underlying disease was slow; therefore, the attending physician considered the product to be useful in maintaining and improving skin condition. 2.Patient who can be medically examined at 4 and 8 weeks (a deviation of 1 week before or after is allowed) after the start of the study 3.Patient from whom written consent (consent from a legal guardian in case of minors) can be obtained. Further information about age and sex need not be asked.
Key exclusion criteria	1.irritation or an allergic skin reaction because of the use of the product. 2.Patients with severe skin rashes such as contagious impetigo or Kaposi varicelliform eruption in the area where the product was used 3.Patients who cannot be medically examined at 4 and 8 weeks (as a general rule) after the start of the study 4.Patient whose participation in the study is deemed inappropriate by the attending physician
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Furue Middle name Last name Masutaka
Organization	Kyusyu University
Division name	Department of Dermatology, Graduate School of Medical Sciences
Zip code	812-0054
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL	092-642-5596
Email	takeuchs@dermatol.med.kyushu-u.ac.jp

Public contact
1st name of contact person	1st name Satoshi Middle name Last name Takeuchi
Organization	Kyusyu University Hospital
Division name	Dermatology
Zip code	812-0054
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL	092-642-5596
Homepage URL	http://www.kyudai-derm.org/part/treat/recent.html
Email	takeuchs@dermatol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyusyu University Hospital
Institute
Department

Funding Source
Organization	Tokiwa Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyusyu University Hospital Certified Review Board
Address	3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
Tel	092-642-5774
Email	bynintei@jimu.kyushu-u.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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 23 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	20
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	2011 Year 10 Month 19 Day
Date of IRB	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2011 Year 12 Month 21 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008169