UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study about the skin care of the skin disease patient
Title of the study (Brief title)	Clinical study about the skin care of the skin disease patient
Region	Japan

Condition
Condition	Atopic dermatitis, psoriasis, senile xerosis, contact dermatitis, etc.
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For quasi-drug, which was developed as a skin care agent for patients with diseases involving pigmentation and dry skin atopic dermatitis, psoriasis, senile xerosis, such as contact dermatitis, tested the use of 12 weeks, I will make sure it is not safe to use, such as skin irritation. symptoms of dry skin and pigmentation) that target many cases you are also upcoming usability evaluation test.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At the start, 6 weeks later, at the end (12 weeks) to observe the changes in the skin symptoms.
Key secondary outcomes

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	In addition to the usual treatment, test the products to use.
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	Female
Key inclusion criteria	In patients with symptoms of dry skin and pigmentation, target persons who meet the following criteria. In the people of the disease with the symptom of atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and the pigmentation, the use of this study product is a use and a judged person in the treatment of the underlying disease The person that the symptom of the underlying disease is stable by treatment Age, the sex do not matter The person that a written agreement is provided from the person himself
Key exclusion criteria	Person with the experience that produced the skin symptoms such as contact dermatitides by this study product ingredient and similar ingredient Person with the exanthem that is unsuitable for the application of this study product in the application part The person that the symptom of the underlying disease is not stable The person whom (as a general rule) cannot examine 12 weeks later Person of pregnancy and nursing addition, the person that an examination responsibility (allotment) doctor judges the participation in this study to be inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	Katsuko Kikuchi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Address	Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Email

Public contact
Name of contact person	Katsuko Kikuchi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Address	Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	TOKIWA pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 31 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 20 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012043