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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024946
Receipt No. 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

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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)
Email 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
Email akiharu@keio.jp

Sponsor
Institute Keio university school of medicine, Department of dermatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028626

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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