UMIN-CTR Clinical Trial

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
Email	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
Email	ctsodan@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033410