UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017957 |
|---|---|
| Receipt number | 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 09:31:06 |
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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
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
h-murota@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept of dermatology, Osaka university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020812
