UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010299 |
|---|---|
| Receipt number | R000012057 |
| Scientific Title | The effect of the recurrence of atopic dermatitis by external steroid ointment |
| Date of disclosure of the study information | 2013/03/22 |
| Last modified on | 2019/09/25 17:12:51 |
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Basic information
Public title
The effect of the recurrence of atopic dermatitis by external steroid ointment
Acronym
The effect of the recurrence of atopic dermatitis by external steroid ointment
Scientific Title
The effect of the recurrence of atopic dermatitis by external steroid ointment
Scientific Title:Acronym
The effect of the recurrence of atopic dermatitis by external steroid ointment
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect by the gradual loss of betamethasone butyrate propionate ester (BBP) ointment for the moderate level atopic dermatitis patient is compared and is examined from effectiveness, patient QOL and recurrence of the efflorescence between humidity retention medicine administrated group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of atopic dermatitis (EASI, SCORAD, IGA)
Blood examination (TARC, LDH, number of eosinophil)
QOL of patients (DLQI)
Severity of itching (Visual Analogue Scal)
Existence of the recurrence and period to the recurrence
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The 2 week external steroid ointment (betamethasone butyrate propionate ester ointment) is applied, after the skin eruption is improved
Interventions/Control_2
Only the moisturizing agent is immediately applied externally, after the efflorescence is improved
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
moderate level of atopic dermatitis over 18 years old
Key exclusion criteria
The patient with the contact sensitivity in the external drug
Pregnant woman or may patient
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Utani |
Organization
Nagasaki university hospital
Division name
Dermatology and allergology
Zip code
Address
1-7-1 sakamoto, Nagasaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoi Takenaka |
Organization
Nagasaki university hospital
Division name
Dermatology and Allergology
Zip code
Address
TEL
095-819-7333
Homepage URL
Sponsor or person
Institute
Nagasaki university hospital
Department of Dermatology and Allergology
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 03 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.mh.nagasaki-u.ac.jp/research/rinsho/index.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.mh.nagasaki-u.ac.jp/research/rinsho/index.html
Number of participants that the trial has enrolled
4
Results
The group that continued topical use of steroids for 2 weeks after remission and then switched to moisturizer tended to have a longer time to relapse than the group that switched to moisturizer immediately after remission. However, there was no difference in the degree of symptoms at the time of relapse. In all cases, TARC decreased at the time of remission. However, the number of cases was small, and a statistical study could not be performed.
Results date posted
| 2019 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
atopic dermatitis over 18 years old
Participant flow
Use betamethasone butyrate propionate ointment to relieve symptoms. After that, divide the group using only moisturizer and the group that used the drug for 2 weeks after remission, and consider the period until recurrence.
Adverse events
none
Outcome measures
Period until recurrence after relieving skin symptoms
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012057
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
