UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006955 |
|---|---|
| Receipt number | R000008212 |
| Scientific Title | The effect of proactive therapy with tacrolimus and betamethasone butyrate on atopic dermatitis: Randomized placebo-controlled study |
| Date of disclosure of the study information | 2011/12/26 |
| Last modified on | 2018/12/31 09:20:12 |
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Basic information
Public title
The effect of proactive therapy with tacrolimus and betamethasone butyrate on atopic dermatitis: Randomized placebo-controlled study
Acronym
The effect of proactive therapy on atopic dermatitis: Randomized placebo-controlled study
Scientific Title
The effect of proactive therapy with tacrolimus and betamethasone butyrate on atopic dermatitis: Randomized placebo-controlled study
Scientific Title:Acronym
The effect of proactive therapy on atopic dermatitis: Randomized placebo-controlled study
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of proactive therapy with anti-inflammatory ointment on atopic dermatitis, we have conducted the randomized placebo-controlled study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. SCORAD (severity score)
b. investigator's global assessment
c. safety (comparing between tacrolimus and steroid ointment)
d. serum cortisol
e. serum TARC
f. DLQI (QoL)
g. intensity of itch
h. history of usage of external medicine
i. adverse/side effect
j. length of remission
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
group 1:tacrolimus
Interventions/Control_2
group 2: betamethasone butyrate
Interventions/Control_3
group 3: vaceline(placebo)
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
Adult (>20 years old) patients with atopic dermatitis with agreement to this sudy
Key exclusion criteria
1. Cases who are discouraged to use tacrolimus or steroid ointment.
2. Cases with intorelance to these ointment.
3. pregnant woman
4. cases who are judged to discourage by attending physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Murota |
Organization
Osaka university
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka, SUita, Osaka
TEL
0668795111
h-murota@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | 0668795111 |
Organization
Osaka university
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka
TEL
0668795111
Homepage URL
h-murota@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept of dermatology, Osaka university
Institute
Department
Personal name
Funding Source
Organization
Dept of dermatology, Osaka university
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
| 2011 | Year | 12 | Month | 26 | 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
| 2011 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | 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
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008212
