UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038772
Receipt number R000044191
Scientific Title Improvement of the skin quality through the application of glycogen
Date of disclosure of the study information 2019/12/04
Last modified on 2020/06/03 09:17:59

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Basic information

Public title

Improvement of the skin quality through the application of glycogen(0.3%)

Acronym

Improvement of the skin quality through the application of glycogen

Scientific Title

Improvement of the skin quality through the application of glycogen

Scientific Title:Acronym

Improvement of the skin quality through the application of glycogen

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the improvement of the skin quality from using glycogen lotion or glycogen cream (0.3%)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Indexes for skin conditions (stratum corneum moisture content, transepidermal water loss) and questionnaire (water amount, drying)

Key secondary outcomes

Lightness, spots, pores, moisture content, viscoelasticity, transepidermal water loss, wrinkles, questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply placebo cosmetics (lotion or cream) continuously for 4 weeks

Interventions/Control_2

Apply test cosmetics (lotion or cream) continuously for 4 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

45 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Those who can strictly follow the usage
2.Japanese healthy men and women from 45 to 59 years old
3.Those who feel lack of elasticity or moisture

Key exclusion criteria

1.Those who have a medical history of allergies to cosmetics
2.Those who have received hormone replacement therapy
3.Those who are pregnant, breastfeeding, or have a possibility of pregnancy
4.Those who have experience in beauty treatment such as aesthetics that affect the test site
5.Those who consume alcohol excessively
6.Persons whose lifestyle may change during the test period (night work, long trip, etc.)
7.Those who had participated within 4 weeks or are participating in other clinical trials
8.Those who are determined to be unsuitable for this study by the person in charge of the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Nishiura

Organization

R&D Skin Research Center, Basic Reserch, Nihon Kolmar Co., Ltd.

Division name

R&D Skin Research Center, Basic Reserch, Nihon Kolmar Co., Ltd.

Zip code

541-0042

Address

1-6-19, Imabashi, Chuo-ku, Osaka, Japan

TEL

06-6203-8520

Email

nishiura@kolmar.co.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Yatsuhashi

Organization

Ezaki Glico Co., Ltd.

Division name

Institute of Health Sciences

Zip code

555-8502

Address

4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan

TEL

81-6-6477-8425

Homepage URL


Email

hiroko.yatsuhashi@glico.com


Sponsor or person

Institute

Glico Nutrition Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Glico Nutrition 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

R&D Kashiwara Laboratory, Nihon Kolmar Co., Ltd.

Address

16-2, Enmyo-cho, Kashiwara-city, Osaka

Tel

072-977-9431

Email

nob@kolmar.co.jp


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

2019 Year 12 Month 04 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

20

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

2019 Year 11 Month 08 Day

Date of IRB

2019 Year 11 Month 08 Day

Anticipated trial start date

2019 Year 11 Month 08 Day

Last follow-up date

2019 Year 12 Month 06 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 12 Month 03 Day

Last modified on

2020 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044191


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name