UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010285
Receipt No. R000012043
Scientific Title Clinical study about the skin care of the skin disease patient
Date of disclosure of the study information 2013/04/01
Last modified on 2018/04/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study about the skin care of the skin disease patient
Acronym Clinical study about the skin care of the skin disease patient
Scientific Title Clinical study about the skin care of the skin disease patient
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address Seiryo-machi 2-1, Aoba-ku, Sendai 980-8575, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuko Kikuchi
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.