UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012829 |
|---|---|
| Receipt number | R000014986 |
| Scientific Title | Clinical test for development of novel skin care method by augmentation of Staphylococcus epidermidis, an autologous skin microbiota |
| Date of disclosure of the study information | 2014/01/12 |
| Last modified on | 2014/01/13 15:45:08 |
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Basic information
Public title
Clinical test for development of novel skin care method by augmentation of Staphylococcus epidermidis, an autologous skin microbiota
Acronym
Clinical test for development of novel skin care method by augmentation of Staphylococcus epidermidis, an autologous skin microbiota
Scientific Title
Clinical test for development of novel skin care method by augmentation of Staphylococcus epidermidis, an autologous skin microbiota
Scientific Title:Acronym
Clinical test for development of novel skin care method by augmentation of Staphylococcus epidermidis, an autologous skin microbiota
Region
| Japan |
Condition
Condition
Improvement of skin moisture retention
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of augmentation of Staphylococcus epidermidis on skin condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of skin moisture retention and rough skin textures.
Low possibility of side effects induced by augmentation of S. epidermidis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
[Group I]
Subjects applied their individualized S. epidermidis sample, which were lyophylized.The application of the individualized S. epidermidis sample to the skin surface of the face was performed twice per week for four weeks before sleeping.
A lyophylized powder of skimmed milk without their individualized S. epidermidis was used for four weeks from the 5th week.
Interventions/Control_2
[Group II]
Subjects applied a lyophylized powder of skimmed milk without their individualized S. epidermidis as placebo. The application of the individualized S. epidermidis sample to the skin surface of the face was performed twice per week for four weeks before sleeping.
The individualized S. epidermidis sample was used for four weeks from the 5th 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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Skin condition: a subject who feels low moisture retention.
Age: a subject who is 20 to 60 years old at the time of informed consent.
Sex: don't ask
Key exclusion criteria
Patients were excluded if they had any dermatological disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Nodake |
Organization
Nagasaki International University
Division name
Laboratory of Biochemistry, Department of Pharmacy, Faculty of Pharmaceutical Sciences
Zip code
Address
2825-7 Huis Ten Bosch, Sasebo, Nagasaki 859-3298, Japan
TEL
0956-20-5737
nodake@niu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Tsutsumida |
Organization
Nagasaki International University
Division name
Section of General Affairs
Zip code
Address
2825-7 Huis Ten Bosch, Sasebo, Nagasaki 859-3298, Japan
TEL
0956-39-2020
Homepage URL
tsutsumida@niu.ac.jp
Sponsor or person
Institute
Nagasaki International University
Institute
Department
Personal name
Funding Source
Organization
SAITO HO-ON KAI Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
長崎国際大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 12 | 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
The augmentation of S. epidermidis increased the lipid content of the skin and improved moisture retention. This treatment also improved any rough skin texture and maintained a low acidic condition on the skin surface. There were few undesirable effects caused by the augmentation of S. epidermidis as was demonstrated by measuring erythema and melanin levels.
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
| 2012 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 11 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 11 | Day |
Last modified on
| 2014 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014986
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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