UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008726 |
|---|---|
| Receipt number | R000010252 |
| Scientific Title | A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis. |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2012/08/20 13:30:08 |
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Basic information
Public title
A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Acronym
A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Scientific Title
A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Scientific Title:Acronym
A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study to investigarte protective effects of a hydrogel dressing product from excerbation of atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the severity of dermatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
hydrogel dressing product
Interventions/Control_2
LIDOMEX
Interventions/Control_3
HIRUDOID
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
Patients with atopic dermatitis of moderate or more
Key exclusion criteria
Patients with oral steroids or oral cyclosporine
Patients with a history of allergy for Ridomekkusu lotion, ointment, lotion Hirudoido ® or hydrogels
Patients suspected of being pregnant or pregnant women
Patients deemed inappropriate by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masutaka Furue |
Organization
Kyusyu University Hospital
Division name
Dermatology
Zip code
Address
3-1-1Umadashi, higasi-ku, Fukuoka-city, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyusyu University Hospital
Division name
Dermatology
Zip code
Address
3-1-1Umadashi, higasi-ku, Fukuoka-city, Fukuoka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kyusyu University Hospital
Institute
Department
Personal name
Funding Source
Organization
ALCARE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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 | 08 | Month | 20 | 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
| 2011 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 15 | 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 | 20 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010252
