UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024946 |
|---|---|
| Receipt number | R000028626 |
| Scientific Title | Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2018/04/16 10:24:44 |
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Basic information
Public title
Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms
Acronym
Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms
Scientific Title
Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms
Scientific Title:Acronym
Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms
Region
| Japan |
Condition
Condition
Aquagenic wrinkling of the palms, palmoplantar keratoderma, palmoplantar hyperhidrosis, healthy subjects
Classification by specialty
| Dermatology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pathophysiological mechanism that aquagenic wrinkling occurs by comparing the skin between aquagenic wrinkling of the palms, palmoplantar keratoderma, palmoplantar hyperhidrosis and healthy subjects. And also, assessing the safety and efficacy of treatment with non-steroidal anti-inflammatory analgesics by external application.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate degree of maceration before and after water immersion test on each visit.
Key secondary outcomes
Observe the morphology of the palmar skin with an ultrasonic microscope (at the start and the end of the test). Create and compare replica of finger skin print before and after water immersion test (as much as possible on each visit). Self assessment of skin symptoms (per visit).
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
| Medicine |
Interventions/Control_1
Loxoprofen sodium hydrate tape, once a day, pasted on the fingers for 3 to 6 months, 1% diclofenac sodium gel and lotion, topical application to the palm for 3 to 6 months twice a day, 20% or 30% aluminum chloride solution, topical application to the palm for 3 to 6 months twice a day
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have skin maceration by exposure to water with Aquagenic wrinkling of the palms, palmoplantar keratoderma and palmoplantar hyperhidrosis, and healthy subjects
Key exclusion criteria
1) Patients who can not inform disease name.
2) Patients with aspirin asthma and a previous medical history of it.
3) Patients with a history of hypersensitivity to diclofenac sodium, sodium loxoprofen hydrate.
4) Case of pregnancy or expected pregnancy (hope / plan)
5) Cases with age less than 6 at the time of consent acquisition
6) Patients who are judged inappropriate by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiharu Kubo |
Organization
Keio university school of medicine
Division name
Department of dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211(62413)
akiharu@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiharu Kubo |
Organization
Keio university school of medicine
Division name
Department of dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211(62413)
Homepage URL
akiharu@keio.jp
Sponsor or person
Institute
Keio university school of medicine, Department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine, Department of dermatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University Graduate School of Biomedical Engineering
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 | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028626
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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