UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029168
Receipt number R000033281
Scientific Title Therapeutic outcome surveillance of acquired idiopathic generalized anhidrosis (AIGA)
Date of disclosure of the study information 2017/09/19
Last modified on 2020/03/29 12:49:11

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Basic information

Public title

Therapeutic outcome surveillance of acquired idiopathic generalized anhidrosis (AIGA)

Acronym

Therapeutic outcome of AIGA

Scientific Title

Therapeutic outcome surveillance of acquired idiopathic generalized anhidrosis (AIGA)

Scientific Title:Acronym

Therapeutic outcome of AIGA

Region

Japan


Condition

Condition

Acquired idiopathic generalized anhidrosis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

therapeutic outcome study of acquired idiopathic generalized anhidrosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

severity score of AIGA
(area of anhidrosis, area of pain or urticaria)

Key secondary outcomes



Base

Study type

Observational


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

13 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients of Acquired idiopathic generalized anhidrosis who visited Tokyo Medical and Dental University or collaborator

Key exclusion criteria

patients younger than 13 years old

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takichi
Middle name
Last name Munetsugu

Organization

Tokyo Medical And Dental University, Medical Hospital

Division name

Dermatology

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan

TEL

03-3813-6111

Email

mtakderm@tmd.ac.jp


Public contact

Name of contact person

1st name Takichi
Middle name
Last name Munetsugu

Organization

Tokyo Medical And Dental University, Medical Hospital

Division name

Dermatology

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan

TEL

03-3813-6111

Homepage URL


Email

mtakderm@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical And Dental University, Medical Hospita

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical And Dental University, Medical Hospital

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan

Tel

03-3813-6111

Email

mtakderm@tmd.ac.jp


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

2017 Year 09 Month 19 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Outcome research of the AIGA patients


Management information

Registered date

2017 Year 09 Month 16 Day

Last modified on

2020 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033281


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name