UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of skin barrier homeostasis by TRPM8 in ichthyosis
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kimiko Nakajima
Organization	Kochi Medical School, Kochi University
Division name	Department of Dermatology
Address	Kohasu, Okohcho, Nankoku
TEL	088-880-2363
Email	nakajimk@kochi-u.ac.jp

Public contact
Name of contact person	Kimiko Nakajima
Organization	Kochi Medical School, Kochi University
Division name	Department of Dermatology
Address	Kohasu, Okohcho, Nankoku
TEL	088-880-2363
Homepage URL
Email	nakajimk@kochi-u.ac.jp

Sponsor
Institute	Department of Dermatology Kochi Medical School, Kochi University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025364