UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046831 |
|---|---|
| Receipt number | R000053433 |
| Scientific Title | The study of the effectiveness of topical therapy using palmitoleic acid on mild atopic dermatitis skin, and difference of skin microbiota. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/09/13 22:58:07 |
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Basic information
Public title
The study of difference of skin condition and skin microbiota in mild atopic dermatitis due to topical therapy effects of skin microbiota balance.
Acronym
The study of difference of skin condition and skin microbiota in mild atopic dermatitis due to topical therapy.
Scientific Title
The study of the effectiveness of topical therapy using palmitoleic acid on mild atopic dermatitis skin, and difference of skin microbiota.
Scientific Title:Acronym
The study of the effectiveness of topical therapy using palmitoleic acid on mild atopic dermatitis skin.
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of skin condition and microbiota in a normal resident of the skin due to topical therapy using palmitoleic acid, and investigate transepidermal water loss and water content in mild atopic dermatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin condition and distribution of microbiota in a normal resident of the skin
Key secondary outcomes
Transepidermal water loss and water content
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
mild atopic dermatitis patients , twenty years over and less than seventy years, who go to Osaka Medical and Pharmaceutical
University Hospital.
Key exclusion criteria
Atopic dermatitis patients treatmented of Systemic therapy(phototherapy,oral steroid and cyclosporine therapy, biologics, JAK/STAT inhibitors and so on)and atopic dermatitis patients, we judge on themselves, difficult to do the study safely.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Moriwaki |
Organization
Osaka Medical and Pharmaceutical
University Hospital
Division name
Department of Dermatology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki,Osaka
TEL
072-683-1221
shinichi.moriwaki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Moriwaki |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Dermatology
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki,Osaka
TEL
072-683-1221
Homepage URL
shinichi.moriwaki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital department of Dermatology
Institute
Department
Personal name
Funding Source
Organization
Projects to support the advancement of strategic core technologies
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi, Takatsuki,Osaka
Tel
072-683-1221
rinri@ompu.ac.jp
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
大阪医科薬科大学病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe case-control sample, there is a difference of skin condition and skin microbiota due to topical therapy using palmitoleic acid or not.
Management information
Registered date
| 2022 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053433
