UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010191
Receipt number R000011934
Scientific Title The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease
Date of disclosure of the study information 2013/04/01
Last modified on 2016/03/19 14:57:24

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Basic information

Public title

The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease

Acronym

The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease

Scientific Title

The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease

Scientific Title:Acronym

The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease

Region

Japan


Condition

Condition

Drier's disease Hailey-Hailey disease

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The examination of the clinical response of celecoxib in Darier's disease and Hailey-Hailey disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We evaluate it with clinical symptom degree of improvement
1 erythema area
2 erosion area
3 egree of improvement of a pain and itch using a VAS scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

celecoxib

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

A person of Darier disease and Hailey-Hailey disease which was already diagnosed in Juntendo University.

Key exclusion criteria

1 The patients who have an allergy to celecoxib
2 The patients with the aspirin asthma and gastrointestinal ulceration
3 The patients with serious hepatopathy and nephropathy
4 The patients with the heart disease
5 The patients during the pregnancy or breast-feeding

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Takagi

Organization

Juntendo university gradurate school of medicine

Division name

Department of ermatology

Zip code


Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo university gradurate school of medicine

Division name

Department of ermatology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Juntendo university gradurate school of medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo university gradurate school of medicine

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 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

2013 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 08 Day

Last modified on

2016 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name