UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010285 |
|---|---|
| Receipt number | 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 10:22:11 |
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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
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
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012043
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
