UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of proactive therapy with tacrolimus and betamethasone butyrate on atopic dermatitis: Randomized placebo-controlled study
Title of the study (Brief title)	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	Hiroyuki Murota
Organization	Osaka university
Division name	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 university
Division name	Dermatology
Address	2-2, Yamadaoka
TEL	0668795111
Homepage URL
Email	h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute	Dept of dermatology, Osaka university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008212