UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation of novel bath solution
Acronym	Safety evaluation of novel bath solution
Scientific Title	Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis
Scientific Title:Acronym	Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis
Region	Japan

Condition
Condition	Atopic dermatitis, Xerosis and the like with mild to moderate dry skin symptoms
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety and usefulness of the test bath solution after use for 4 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin findings(1) and adverse events(2) : dermatologist examination,questionnaire for skin condition and the impression of test bath solution,recording,daily life (1) 0 week,2 week,4 week (2) 2 week,4 week
Key secondary outcomes	Improvement of dryness and desquamation : dermatologist examination,photographic recording 0 week,2 week,4 week

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	Other
Interventions/Control_1	Use of the test bath solution at least 5 times a week for 4 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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with mild to moderate dry skin symptoms(Atopic dermatitis,Xerosis and the like) 2. Patients with mild to moderate dry skin symptoms at the examination areas 3. Japanese men and women between the ages of 20 and 69 4. Patients giving written informed consent with his or her own will after receiving an adequate information about the test bath solution and aim of this study
Key exclusion criteria	1. Patients with rashes at the examination areas that intervene the evaluation 2. Patients with rosacea-like dermatitis or with steroid skin disease 3. Patients who take or anticipate to take medicines that affect the study such as oral steroids, immunosuppresant 4. Patients who have applied medicine or moisturizing agent over the examination areas 5. Patients who have applied cosmetics or quasi-medicine that have moisturizing effect 6. Pregnant women 7. Lactating women 8. Patients who have experienced severe skin symptoms many times due to the use of cosmetics in the past 9. Patients who are judged as inappropriate by principal investigator or sub-investigator with other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Takano
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name	Center for Clinical Pharmacology
Zip code	004-0839
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL	011-882-0111
Email	takano@ughp-cpc.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Matsuda
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name	Center for Clinical Pharmacology
Zip code	004-0839
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
TEL	011-882-0111
Homepage URL
Email	matsuda@ughp-cpc.jp

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization	Shiseido Japan Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel	011-881-0111
Email	matsuda@ughp-cpc.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	2021 Year 02 Month 19 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
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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 22 Day
Last follow-up date	2021 Year 04 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 19 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049536

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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