UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008794
Receipt number R000010333
Scientific Title Evaluation of the efficacy of external steroid in the treatment of so-called "diaper dermatitis" in elderly patients.
Date of disclosure of the study information 2012/09/01
Last modified on 2014/04/22 16:50:01

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Basic information

Public title

Evaluation of the efficacy of external steroid in the treatment of so-called "diaper dermatitis" in elderly patients.

Acronym

Evaluation of the efficacy of external steroid in the treatment of so-called "diaper dermatitis" in elderly patients.

Scientific Title

Evaluation of the efficacy of external steroid in the treatment of so-called "diaper dermatitis" in elderly patients.

Scientific Title:Acronym

Evaluation of the efficacy of external steroid in the treatment of so-called "diaper dermatitis" in elderly patients.

Region

Japan


Condition

Condition

diaper dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To obtain evidence for the efficacy of external steroid in the treatment of diaper dermatitis in elderly patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Investigator's judgment on the degree and rate of the improvement (based on the severity of rash and the area affected)

Key secondary outcomes

- Days to resolution
- Caretaker's judgment on the degree of the improvement
- Detection of fungi including Candida
- Safety


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

Mixed killed bacterial suspension/ Hydrocortisone combination drug

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have been diagnosed with diaper dermatitis.
2) Patients who received an explanation of the study detail and signed a written consent. Alternatively, the patient's representative may sign a written consent, if the patient is unable to do so.

Key exclusion criteria

1) Patients with a known allergy to any component of the study drug.
2) Patients who are judged inappropriate to participate in the study by the investigator.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Tsunemi

Organization

Tokyo Woman's Medical University

Division name

Dermatology

Zip code


Address

8-1, Kawada-cho, Shinjyuku-ku, Tokyo 162-8666 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

EBMs Co.,Ltd

Division name

Business Strategy Division

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Non-Profit Organization Health Institute Research of Skin

Institute

Department

Personal name



Funding Source

Organization

Non-Profit Organization Health Institute Research of Skin

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

2012 Year 09 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

Completed

Date of protocol fixation

2012 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 09 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



Management information

Registered date

2012 Year 08 Month 28 Day

Last modified on

2014 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name