UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005505 |
|---|---|
| Receipt number | R000006529 |
| Scientific Title | Development of a dermatological device for home use |
| Date of disclosure of the study information | 2011/04/25 |
| Last modified on | 2011/04/25 18:50:34 |
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Basic information
Public title
Development of a dermatological device for home use
Acronym
Development of a dermatological device
Scientific Title
Development of a dermatological device for home use
Scientific Title:Acronym
Development of a dermatological device
Region
| Japan |
Condition
Condition
psoriasis, atopic dermatitis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a handy UV irradiation device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of dermatological symptoms after 4 weeks, 8 weeks, 12 weeks of irradiation
Key secondary outcomes
Improvement of itch after 4 weeks, 8 weeks, 12 weeks of irradiation
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration: 1 year
Wave length: 375 nm
Dose: 26J/cm2
Frequences: 1 or 2 or 3 times per week
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
healthy adults
Key exclusion criteria
if no consent can be obtained
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Nakajima |
Organization
Kochi University, Kochi Medical School
Division name
Department of Dermatology
Zip code
Address
Kohasu, Okoh-cho, Nankoku, Kochi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nakajima |
Organization
Kochi Univerity, Kochi Medical School
Division name
Dermatology
Zip code
Address
TEL
Homepage URL
nakajima@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
TOSADENSHI, 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
| 2011 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
| 2011 | Year | 04 | Month | 25 | Day |
Last modified on
| 2011 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006529
