UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030610 |
|---|---|
| Receipt number | R000033410 |
| Scientific Title | Treatment of alopecia areata with oral tacrolimus |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/07/12 18:33:26 |
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Basic information
Public title
Treatment of alopecia areata with oral tacrolimus
Acronym
AA tacroliums
Scientific Title
Treatment of alopecia areata with oral tacrolimus
Scientific Title:Acronym
AA tacroliums
Region
| Japan |
Condition
Condition
Alopecia areata
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of oral tacrolimus for the treatment of alopecia areata in small groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hair regrowth after 12 week treatment of oral tacrolimus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Acute cases:
Methylprednisolone half pulse (500 mg/d, 3 days) followed by 12 week treatment of oral tacrolimus. Trough serum levels of tacrolimus are controlled at 5-10ng/mL
Chronic cases:
12 week treatment of oral tacrolimus. Trough serum levels of tacrolimus are controlled at 5-10ng/mL
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Confirmation of the diagnosis
Acute cases:
25% or more hair loss in 3 months or less for the first time
Chronic cases:
25% or more hair loss for 6 months or more; uncontrolled by existing treatments
Key exclusion criteria
Heart, kidney, or endocrine disorders
Infectious diseases: viral hepatitis, tuberculosis, syphilis, pneumonia, urinary tract infections
Mental diseases
Current or past cancers
Current or possible pregnancy
Others considered by doctors
Contraindication of oral tacrolimus
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Teruki |
| Middle name | |
| Last name | Dainichi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo, Kyoto 606-8507 Japan
TEL
075-751-3310
dainichi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kuhahara |
Organization
Kyoto University Hospital
Division name
Consultation support center
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo, Kyoto 606-8507 Japan
TEL
075-751-4748
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science (iACT)
Address
54 Shogoin Kawahara-cho, Sakyo, Kyoto 606-8507 Japan
Tel
075-751-4748
ctsodan@kuhp.kyoto-u.ac.jp
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
| 2018 | Year | 04 | 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
| 2017 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 01 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033410
| 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 |
