UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009381 |
|---|---|
| Receipt number | R000011026 |
| Scientific Title | The use testing of moisturizing bath additive (quasi-drugs) for dry skin |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2014/11/23 09:53:50 |
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Basic information
Public title
The use testing of moisturizing bath additive (quasi-drugs) for dry skin
Acronym
The use testing of moisturizing bath additive
Scientific Title
The use testing of moisturizing bath additive (quasi-drugs) for dry skin
Scientific Title:Acronym
The use testing of moisturizing bath additive
Region
| Japan |
Condition
Condition
atopic dermatitis, psoriasis vulgalis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify that the rate of side effects is less than 5%, when patients presenting dry skin use moisturizing bath additives.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After using moisturizing bath additive for 8 weeks, collect the stratum corneum.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use moisturizing bath additive for 8 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It is determined that this product is ueful for treat a patient.
The name of the disease does not matter, if the disease has symptoms of dry skin.
Do not limit the treatment of the underlying disease.
A person 20 years of age or older
Gender does not matter
Those who written informed consent is obtained from
Key exclusion criteria
Those who have experience gave rise to skin conditions such as contact dermatitis due to ingredients and similar components of this study
A person who has improper skin eruption in the application site of this product.
Those who can not (in principle) be examined after 8 weeks
A person under 20
Those who can not judge a person by themselves, such as dementia
An pregnancy and lactation
Those who are deemed inappropriate to participate in this study by doctor.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Miyachi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Dermatology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan
TEL
075-751-3310
hifuka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Fujisawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Dermatology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto, 6068507, Japan
TEL
075-751-3310
Homepage URL
fujiaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Graduate School of Medicine, Kyoto University
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
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 21 | Day |
Last modified on
| 2014 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011026
