UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of anxiety relief program for the itch of patients adult atopic dermatitis
Title of the study (Brief title)	Development of anxiety relief program for the itch of AD
Region	Japan

Condition
Condition	Atopic Dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Adult AD patients strong anxiety, are demonstrated in the anxiety studies to be associated with worsening of skin conditions hitherto. From this relationship, it can be said that the treatment of adult AD patients, it is necessary to focus anxiety. However, so far it is only is taken up anxiety as a characteristic of the adult type AD patients, not tied to the treatment was at present. In such a, adult AD patients became clear that suffer from "anxiety for itch", further "anxiety for itch" affects the scratching behavior through pruritus, it is to reduce the health-related QOL It has been revealed. From this result, reduces itching and scratching behaviors of adult type AD patients, it is necessary treatments that focus on "anxiety for itch" in order to improve the health-related QOL. In this study, carried out the severity evaluation by SCORAD before and after the intervention program for an adult AD patients, this program is to evaluate the effect on the improvement of the rash.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SCORAD
Key secondary outcomes	Blood examination (TARC) Psycholocial test (STAI)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	In addition to the usual treatment for atopic dermatitis, three times a lecture of relaxation using a distraction and muscle relaxation method by 30 minutes of images per week.
Interventions/Control_2	Do only the standard treatment for atopic dermatitis.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients 16 years of age or older of atopic dermatitis
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	Kayoko Matsunaga
Organization	Fujita Health University School of Medicine
Division name	Department of Dermatology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-9256
Email	kamatsu@fujita-hu.ac.jp

Public contact
Name of contact person	Takashi Yamakita
Organization	Fujita Health University School of Medicine
Division name	Department of Dermatology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-9256
Homepage URL
Email	yamakita@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2016 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 13 Day
Anticipated trial start date	2013 Year 09 Month 12 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 08 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2016 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024043