UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
Title of the study (Brief title)	A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
Region	Japan

Condition
Condition	Clinical research paper carried out on healthy subjects not suffering from skin diseases
Classification by specialty	Dermatology Aesthetic surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	From clinical studies conducted on healthy subjects not suffering from skin diseases, clinical research papers were orally ingested by plant-derived glucosylceramide by a systematic analysis method "Systematic Review" We will carry out comprehensive evaluation and verification of effectiveness and safety concerning skin moisture retention (transepidermal water dissipation amount, stratum corneum water content etc.).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the influence of continuous ingestion of food-derived functional ingredient "glucosylceramide" on skin moisturizing
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Gender	Male and Female
Key inclusion criteria	[PICOS] (Patients) Clinical study conducted in Japan for persons not suffering from skin diseases (Interventions) 1. Ongoing intake of glucosylceramide containing supplements 2. Continuous intake of food containing glucosylceramide (Control) as a control composition (control group) 1. Supplements not containing glucosylceramide 2. Foods not containing glucosylceramide (Outcome) Continuous uptake of glucosylceramide improves skin moisturizing function (Example) 1. Evaluation by medical consultation, interview, palpation, visual inspection etc. 2. Measured values such as percutaneous water transpiration amount, horny layer water content (Study design) Placebo or non glucosylceramide as control 1. Double blind parallel group comparison test 2. Single blind parallel group comparison test 3. Double blind crossover comparative test 4. Single blind crossover comparison test Contains glucosylceramide 1. Dose setting test 2. Gradual increase / decrease test [Selection criteria (eligibility criteria)] In the primary screening, among the candidate literatures assumed to be clinical studies concerning the oral intake of plant-derived glucosiceramide targeted to Japanese conducted in Japan by the abstract of Medical Magazine WEB, the following selection criteria Criteria), one corresponding to one or more is taken as a temporary candidate document. 1. Clinical research literature for domestic non-affected persons with skin 2. Literature of clinical research for adults conducted in Japan 3. Clinical research literature extracted by medical magazine WEB of literature retrieval system 4. Clinical research literature conducted by public institutions 5. Clinical research literature published by National Institute of Research and Technology Agriculture Food Industry Research Organization (Agricultural Research Organization) 6. Clinical research literature adopted by the reviewer's agreement besides the medical magazine WEB
Key exclusion criteria	[Exclusion Criteria] In the secondary screening, provisional candidate documents are obtained by the abstract, and those corresponding to one or more of the following exclusion criteria are excluded from the candidate literature. 1. Clinical research literature for subjects suffering from skin diseases 2. Literature of clinical research for minors 3. Clinical research literature for pregnant women and lactating women 4. Clinical research literature not reviewed 5. Literature of clinical study without comparative control group 6. Literature of clinical study in which the main involved component is not glucosylceramide 7. Clinical research literature which can not be evaluated by glucosylceramide and other equivalent ingredients 8. In addition, clinical research literature judged inappropriate by the reviewer's agreement
Target sample size	1

Research contact person
Name of lead principal investigator	Toru Urakawa
Organization	Adaptgen Pharmaceutical Co., Ltd.
Division name	Sales Planning Division & Clinical development division
Address	1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
TEL	0572-56-1111
Email	adurakawa@adaptgen.co.jp

Public contact
Name of contact person	Toru Urakawa
Organization	Adaptgen Pharmaceutical Co., Ltd.
Division name	Sales Planning Division & Clinical development division
Address	1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
TEL	0572-56-1111
Homepage URL
Email	adurakawa@adaptgen.co.jp

Sponsor
Institute	Adaptgen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Adaptgen Pharmaceutical Co., Ltd.
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 16 Day
Anticipated trial start date	2017 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 02 Month 08 Day
Date analysis concluded	2017 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Relationship between the results of research review and the functionality to be displayed As a result of the SR study, the outcome with respect to the RQ / QC set for the functionality (effectiveness) given to a person by the functional participating component glucosylceramide is to consume glucosylceramide continuously from 0.6 mg to 4.0 mg per day By improving the barrier function of the skin and water retention ability and improving the moisturizing function "as confirmed by this SR research, the ancestor and divergence between the display contents and the literature It can be denied. Also regarding safety, there were no adverse events that glucosylceramide is considered to be a direct cause, and certain safety was also confirmed.
Other related information	(Data extraction process) In Adaptogen Pharmaceutical Co., Ltd., "Guidelines on Notification of Functional Displayed Foods" and "Ethical Guidelines on Medical Research for Human Subjects" notified by regulatory authorities in accordance with the Functionally Displayed Food System, and other related laws, guidelines, and guidelines Based on the notification, "Standard Operating Procedure for Functionally Displayed Food etc." was established and the evaluation verification method by the systematic analysis method "Systematic Review" of the clinical research paper and the revision of the patent law (April 1, 2016) Provisions and procedures have been established and operated taking intellectual property rights (patent rights, utility model rights, design rights, trademark rights, copyrights, unfair competition prevention laws and related laws) into consideration. (Reliability and Evaluation Criteria in Clinical Research) About the evaluation of the bias risk that can be investigated with reference to "ethical guidelines on research on medical science for human beings" and GCP ministerial ordinance, Collaboration , Clinical trials including clinical physicians, clinical trial investigations committee,ethical review committee, medical experts and experts in basic research field, and 14 bias risk evaluation items and individual research bias risk The comprehensive evaluation criteria of.

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029632