UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025770 |
|---|---|
| Receipt number | R000029148 |
| Scientific Title | Effective comparative study of moisture cream for itching in the senile dry skin |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/01/20 17:35:19 |
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Basic information
Public title
Effective comparative study of moisture cream for itching in the senile dry skin
Acronym
The influence of moisture cream for itching by dry skin
Scientific Title
Effective comparative study of moisture cream for itching in the senile dry skin
Scientific Title:Acronym
The influence of moisture cream for itching by dry skin
Region
| Japan |
Condition
Condition
asteatotic eczema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of moisture cream for itching by dry skin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the skin severity index on 4 weeks after study starting
Key secondary outcomes
Investigating of VAS for itching,water content in the corneal layer,TEWL,the nerve perception for the skin stimulation, analysis of the corneal layer by ELISA and immunostaining on 4 weeks after study starting
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients apply medical white vaseline and cosmetics cream to the leg of right and left twice a day each at random for four 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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The man and woman who has a dry symptom of the skin with itching including dermatitis to a leg 60 years or older
Key exclusion criteria
The person who produced the exacerbation of a contact dermatitis and the itch by the ingredient included in this study product in the past
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Katayama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
2-2 yamadaoka Suita city, Osaka
TEL
06-68779-3031
katayama@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saori ochi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
2-2 yamadaoka Suita city, Osaka
TEL
06-6879-3031
Homepage URL
102itoi@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Osaka 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
| 2017 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | 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
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029148
