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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017630 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Dermatology, Graduate School of Medicine, Kyoko University |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020430 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |