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
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
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
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
