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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name