UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022011 |
|---|---|
| Receipt number | R000025364 |
| Scientific Title | Assessment of skin barrier homeostasis by TRPM8 in ichthyosis |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2016/04/25 14:35:42 |
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Basic information
Public title
Assessment of skin barrier homeostasis by TRPM8 in ichthyosis
Acronym
Assessment of skin barrier homeostasis by TRPM8 in ichthyosis
Scientific Title
Assessment of skin barrier homeostasis by TRPM8 in ichthyosis
Scientific Title:Acronym
Assessment of skin barrier homeostasis by TRPM8 in ichthyosis
Region
| Japan |
Condition
Condition
skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine skin barrier homeostasis by TRPM8 in pathogenesis of ichthyosis
Basic objectives2
Others
Basic objectives -Others
To examine the improvement of ichthyosis by menthol treatment via TRPM8 channel.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The improvement of histopathological findings four weeks
after menthol treatment
Key secondary outcomes
The value of skin moisture content 4 weeks after menthol treatment
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with ichthyosis
Key exclusion criteria
Other skin inflammatory diseases
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
Kohasu, Okohcho, Nankoku
TEL
088-880-2363
nakajimk@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
Kohasu, Okohcho, Nankoku
TEL
088-880-2363
Homepage URL
nakajimk@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology
Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization
Other
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
高知大学医学部附属病院(高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the improvement of ichthyosis using the histopathological findings and skin moisture content after mentholtreatment
Management information
Registered date
| 2016 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | 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=R000025364
