UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Searching for the optimal cyclosporin A treatment method for atopic dermatitis
Title of the study (Brief title)	Treatment with cyclosporin A for atopic dermatitis
Region	Japan

Condition
Condition	atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, usage of cyclosporin A to atopic dermatitis covered by insurance. However, its administration method has not been established. The aim of this study is to establish the safety and efficacy of cyclosporin A against atopic dermatitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) severity of atopic dermatitis with scoring by Rajka&Langeland. 2) serum TARC level 3) used amount of ointment. 4) ratio and duration of disease flare-up. 5) QOL with DLQI, itch VAS, and sleep disturbance VAS.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cessation of drug after 3 months (no dose reduction)
Interventions/Control_2	cessation of drug after 3 months (dose reduction)
Interventions/Control_3	continuous dosing (no dose reduction)
Interventions/Control_4	continuous dosing (dose reduction)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) diagnosis of severe atopic dermatitis 2) intractable case with atopic dermatitis (resistant with ordinary dose of steroid ointment application) 3)over 16 years old 4) acceptable economic matters for patients 5) patients are no contraindication to cyclosporin A. 6) Regardless of gender
Key exclusion criteria	1) patients are contraindication to cyclosporin A 2) patients are required careful administration of cyclosporin A 3) Patients during the PUVA therapy 4) excluding at aphysician's direction
Target sample size	40

Research contact person
Name of lead principal investigator	HIROYUKI MUROTA
Organization	Osaka university
Division name	Dept. of dermatology
Address	2-2, Yamadaoka, Suita, Osaka
TEL	0668795111
Email	h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	0668795111
Organization	Osaka univeristy
Division name	Dermatology
Address	2-2, Suita
TEL	0668795111
Homepage URL
Email	h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute	Osaka univeristy
Institute
Department

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)

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	2010 Year 09 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 02 Month 13 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 09 Month 28 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005038