UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of moisturizer on both sweating function and sensitive skin in patients with atopic dermatitis, a randomized comparative study
Title of the study (Brief title)	The effect of moisturizer on atopic dermatitis, a randomized comparative study
Region	Japan

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

Objectives
Narrative objectives1	It has been reported that both abnormal sweat function and hypersensitivity of skin contributes to exacerbation of atopic dermatitis. To evaluate the impact of moisturizer, which contains ceramide and eucalyptus oil, on both sweat function and sensitive skin, we conducted a randomized placebo-controlled study. In this study, skin barrier function, sweating function, skin sensitivity, and contents in stratum corneum will be measured.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	barrier function, sweating function, sensitivity of skin
Key secondary outcomes	skin manifestations, contents of stratum corneum.

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	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	ceramide-containing cream will be topically applied to fore arm with twice per day for 4 week.
Interventions/Control_2	placebo cream are topically applied to fore arm with twice per day for 4 week.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Adult male and female 2. atopic dermatitis 3. itching on the cubital fossa 4. with written informed consent 5. subjects, who can visit clinic 3 times (2weeks of interval) for 4 weeks.
Key exclusion criteria	1. most severe case with atopic dermatitis 2. taking oral steroid 3. taking oral cyclosporine 4. receiving UV therapy 5. trauma on the testing area 6. frequent sun exposure 7. severe pollinosis 8. pregnancy 9. alcohol drinker 10. person in the other' drugs' clinical trial 11. person who got massage or skin treatment within the past 4 weeks 12. having allergy to external treatment 13. person who are thought to be a un appropriate 14. person related to this study
Target sample size	25

Research contact person
Name of lead principal investigator	Hiroyuki Murota
Organization	osaka university
Division name	dermatology
Address	2-2, Yamadaoka, Suita
TEL	06-6879-3031
Email	h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	Hiroyuki Murota
Organization	osaka university
Division name	dermatology
Address	2-2, Yamadaoka, Osaka
TEL	0668793031
Homepage URL
Email	h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute	Dept of dermatology, Osaka university
Institute
Department

Funding Source
Organization	department 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	2015 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 18 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 18 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=R000020812