UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Validation Study of an Extract of Koji, Aspergillus kawachii, on Skin Condition and Safety Evaluation of Long-Term Intake of the Extract.
Title of the study (Brief title)	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	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Internal Department
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	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Clinical Trial
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022818