UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017630 |
|---|---|
| Receipt number | R000020430 |
| Scientific Title | A study on the dermatological efficacy and safety of physical therapy for healthy skin |
| Date of disclosure of the study information | 2015/05/25 |
| Last modified on | 2016/09/28 09:30:45 |
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Basic information
Public title
A study on the dermatological efficacy and safety of physical therapy for healthy skin
Acronym
Efficacy test of physical therapy for skin
Scientific Title
A study on the dermatological efficacy and safety of physical therapy for healthy skin
Scientific Title:Acronym
Efficacy test of physical therapy for skin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the dermatological efficacy and safety of physical therapy for healthy female skin around eye area.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the stratum corneum water content, the transepidermal water loss, the skin color and the dermatological assessment after the single treatment and the repeated treatment for 2 and 4 weeks with the physical therapy.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the physical therapy and placebo therapy for skin around eye area for 10 minutes once a day for 4 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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
1.Subjects with atopic dermatitis, eczema and pollen allergy
2.Pregnancies and lactations
3.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kabashima |
Organization
Graduate School of Medicine, Kyoko University
Division name
Department of Dermatology
Zip code
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL
075-751-3310
kaba@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kabashima |
Organization
Graduate School of Medicine, Kyoko University
Division name
Department of Dermatology
Zip code
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan 6068507
TEL
075-751-3310
Homepage URL
kaba@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Graduate School of Medicine, Kyoko University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
京都大学大学院皮膚科（京都府）
Department of Dermatology, Graduate School of Medicine, Kyoko University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 25 | 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
| 2015 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | 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
| 2015 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020430
| Research Plan | |
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| 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 |
