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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017957
Receipt No. R000020812
Scientific Title The effect of moisturizer on both sweating function and sensitive skin in patients with atopic dermatitis, a randomized comparative study
Date of disclosure of the study information 2015/06/18
Last modified on 2018/12/31

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Basic information
Public title The effect of moisturizer on both sweating function and sensitive skin in patients with atopic dermatitis, a randomized comparative study
Acronym The effect of moisturizer on atopic dermatitis, a randomized comparative study
Scientific Title The effect of moisturizer on both sweating function and sensitive skin in patients with atopic dermatitis, a randomized comparative study
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Murota
Organization osaka university
Division name dermatology
Zip code
Address 2-2, Yamadaoka, Suita
TEL 06-6879-3031
Email h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Murota
Organization osaka university
Division name dermatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 01 Month 08 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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