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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012829
Receipt No. 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

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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
Email 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
Email tsutsumida@niu.ac.jp

Sponsor
Institute Nagasaki International University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014986

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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