UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023631 |
|---|---|
| Receipt number | R000027215 |
| Scientific Title | Prevening effect of bath additives for dry skin and itch. |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2016/08/15 13:43:15 |
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Basic information
Public title
Prevening effect of bath additives for dry skin and itch.
Acronym
Prevening effect of bath additives for dry skin and itch.
Scientific Title
Prevening effect of bath additives for dry skin and itch.
Scientific Title:Acronym
Prevening effect of bath additives for dry skin and itch.
Region
| Japan |
Condition
Condition
Xerosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preventing effect of bath additives for dry skin and itch.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin condition:dry skin, scale, erythema
itch: VAS
TEWL, SH, Sebum
(first vist,4 weeks, 8 weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Duration: 8 weeks
soak in the bathtub with bath additives more than 4 times a week
Interventions/Control_2
Duration: 8 weeks
soak in the bathtub without bath additives more than 4 times a week
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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1)have dry skin on the lumbar area or legs in autum and winter seasons.
2)soak in the bathtub more than 4 times a week
3)written informed consent
Key exclusion criteria
1)not apropriate to registration
2)have skin troubles except for dry skin
3)have medical treatment due to skin disease
4)put moisturizing cream on the entire body
5)soak in the bathtub less than 3 times a week
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masako Minami-Hori |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL
0166-68-2523
masakoh@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masako Minami-Hori |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL
0166-68-2523
Homepage URL
masakoh@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Shiseido.Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
EXAM.Co
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
| 2016 | Year | 08 | Month | 16 | 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
| 2016 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
| 2016 | Year | 08 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027215
| 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 |
