UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015134 |
|---|---|
| Receipt number | R000017602 |
| Scientific Title | The skin test environmental improvement by health care use. |
| Date of disclosure of the study information | 2014/09/12 |
| Last modified on | 2015/04/27 12:58:49 |
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Basic information
Public title
The skin test environmental improvement by health care use.
Acronym
The skin test environmental improvement by health care use.
Scientific Title
The skin test environmental improvement by health care use.
Scientific Title:Acronym
The skin test environmental improvement by health care use.
Region
| Japan |
Condition
Condition
Dry skin
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the skin condition of the new product group and the current product group and the control group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inspection score (dryness)
Key secondary outcomes
Inspection score (erythema),Skin moisturizing,Transepidermal water loss and determination in enlarged photograph , subject questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
control group
Interventions/Control_2
current product group
Interventions/Control_3
new product group
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Person of dry skin.
Key exclusion criteria
1)Heavy sequela or severe disease.
2)Heavy atopic dermatitis or systemic skin diseases such as psoriasis.
3)Systemic administration of immunosuppressive drugs or steroids.
4)The person who is unsuitable for the entry judged by a doctor.
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Isoda, M.D.,Ph.D. |
Organization
Mie University Hospital
Division name
Dermatology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
isoda@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Umeda,Ph.D. |
Organization
KSK Laboratories,Inc.
Division name
representative
Zip code
Address
t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL
059-253-8091
Homepage URL
http://www.ksk-lab.co.jp
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KSK Laboratories,Inc.
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
三重大学総合研究棟２
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 12 | 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
| 2014 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 13 | 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
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2015 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017602
| 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 |
