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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019758
Receipt No. R000022818
Scientific Title A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Date of disclosure of the study information 2017/03/11
Last modified on 2017/09/21

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Basic information
Public title A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Acronym A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Scientific Title A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Scientific Title:Acronym A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Region
Japan

Condition
Condition N/A (healthy adults or adults with obese tendencies)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of oral administration of a Koji extract on skin condition and the safety of long-term intake of the extract.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes <Efficacy>
Transepidermal water loss, skin moisture, wrinkle topography, assessment of skin condition by a skin specialist, questionnaires about skin condition.
<Safety>
Blood pressure, pulse, body weight,
body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor.
Key secondary outcomes <Efficacy>
Color difference, melanin, erythema, image analysis of face skin by VISIA, texture of skin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 200 mg of a Koji extract, once-daily for 12 weeks
Interventions/Control_2 200 mg of placebo, not including the Koji extract, once-daily for 12 weeks
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
30 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1) Female aged from 30 to 49 years, when giving the informed consent.
2) Healthy individuals not having any chronic diseases or dermatoses.
3) Individuales who have dry skin and shallow wrinkles.
4) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5) Individuals who can accomplish their tasks in the study at the appointed date
6) Individuals who are judged suitable for this study by the investigator.
Key exclusion criteria Individuals written in below,
-who have some diseases with drug therapy,
-who onsecutively receive medications for treatment of disease in the last 1 month,
-who have severe disease histories in liver, kidney, heart, lung, blood or other tissues,
-who have comorbidity or disease history in respiratory system,
-whose systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg, respectively,
-who have donated over 200 or 400 mL of blood in the last 1 or 3 months,
-who have severe anemia,
-who could have some allergy to the test diet, foods or medicines,
-who are pregnant, breastfeeding, or planning to be pregnant in the near future,
-who are alcoholic or have mental disorder,
-who have smoking habit,
-who have irregular defecation,
-who could change their life style during the study,
-whose skin is extremely sensitive, or who have chronic ruddy complexion, outstanding pores or freckles,
-who have some skin diseases such as atopic dermatitis,
-who could have a seasonal allergy,
-who have severe menopausal symptoms,
-who have severe poor circulation,
-who cannot care their skin enough,
-who are willing to get sunburn, spend long time outdoors during the study,
-who habitually intaked functional or healthy foods or supplements that could get skin condition better in the last 3 months, or who are planning to intake them during the study,
-who habitually consume cosmetics or foods made of Koji,
-who routinely used pharmaceuticals that could get skin condition better in the last 3 months,
-who use cosmetics that could have strong effects on skin moisture or wrinkles,
-who received a surgery on their faces or arms in the last 6 months,
-who participated in other clinical trials in the last 3 months,
-who and whose family work for a company manufacturing or selling healthy foods, functional foods or cosmetics,
-who are judged unsuitable for this study by the investigator for other reasons,
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Nakata
Organization Medical Corporation Bokushinkai CLINTEXE Clinic
Division name Internal Department
Zip code
Address 4F Atago Greenhills MORI Tower, 2-5-1 Atago, Minato-ku, Tokyo, Japan
TEL 03-3432-5021
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd
Division name Department of Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-6801-8480
Homepage URL
Email t.tamura@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization Kirin Company, Limited
Organization
Division
Category of Funding Organization Profit organization
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 株式会社TESホールディングス肌関連試験用検査施設 (TES Holdings Inspection Facilities for Skin Tests)
医療法人社団和啓会メディクス本郷クリニック (Medical Corporation Wakei Kai MEDICS Hongo Clinic)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 11 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 Completed
Date of protocol fixation
2015 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 14 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 11 Month 12 Day
Last modified on
2017 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022818

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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