UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025759
Receipt number R000029632
Scientific Title A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"
Date of disclosure of the study information 2017/01/20
Last modified on 2017/02/08 09:47:10

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Basic information

Public title

A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"

Acronym

A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"

Scientific Title

A systematic review on the improvement of skin moisture retention by the functional participating component "glucosylceramide"

Scientific Title:Acronym

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

1st name
Middle name
Last name Toru Urakawa

Organization

Adaptgen Pharmaceutical Co., Ltd.

Division name

Sales Planning Division & Clinical development division

Zip code


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

1st name
Middle name
Last name Toru Urakawa

Organization

Adaptgen Pharmaceutical Co., Ltd.

Division name

Sales Planning Division & Clinical development division

Zip code


Address

1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan

TEL

0572-56-1111

Homepage URL


Email

adurakawa@adaptgen.co.jp


Sponsor or person

Institute

Adaptgen Pharmaceutical Co., Ltd.

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 20 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

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.

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

2017 Year 01 Month 16 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name