UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of pathophysiology and treatment of aquagenic wrinkling of the palms
Title of the study (Brief title)	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	Akiharu Kubo
Organization	Keio university school of medicine
Division name	Department of dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211(62413)
Email	akiharu@keio.jp

Public contact
Name of contact person	Akiharu Kubo
Organization	Keio university school of medicine
Division name	Department of dermatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 10 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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