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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008794
Receipt No. 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

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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
Institute Non-Profit Organization Health Institute Research of Skin
Institute
Department

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
URL(English) https://upload.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


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