UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026482
Receipt number R000030416
Scientific Title A study for improving effects on the skin by a beauty beverage containing plant extracts
Date of disclosure of the study information 2017/03/22
Last modified on 2021/03/23 10:41:22

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Basic information

Public title

A study for improving effects on the skin by a beauty beverage containing plant extracts

Acronym

A study for improving effects on the skin by a beauty beverage containing plant extracts

Scientific Title

A study for improving effects on the skin by a beauty beverage containing plant extracts

Scientific Title:Acronym

A study for improving effects on the skin by a beauty beverage containing plant extracts

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy of beauty beverages on the skin in healthy females

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the stratum corneum water content, transepidermal water loss, the amount of lactate acid and blood flow measurement after ingestion of a beauty beverage containing plant extracts

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Ingestion of a beauty beverage containing plant extracts -> wash out -> Ingestion of placebo beverage

Interventions/Control_2

Ingestion of placebo beverage -> wash out -> Ingestion of a beauty beverage containing plant extracts

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

25 years-old <=

Age-upper limit

39 years-old >=

Gender

Female

Key inclusion criteria

1. Healthy female aged from 25 to 39 years old.
2. Person who have been feeling stressed for one or two months.
3. Person who worry the cold of hand and foot.
4. Person who have clear scaling and whose stratum corneum water content are low on the face.
5. Person whose menstrual cycles are from 25 to 30days.
6. Person whose body math indexes are from 18.5 or more to 25 less than 25.0.
7. Person whose diastolic blood pressures are less than 90mmHg and systolic ones less than 140mmHg.
8. Person who can agree to participate in the study voluntarily in writing.
9. Person who can agree not to ingest foods and supplements for beauty during the test period.

Key exclusion criteria

1. Person who has abnormalities in the skin of the measurement region
2. Person who regularly goes to hospital.
3. Person with the anamnesis of an alcohol or drug dependence.
4. Person who regularly use drug (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc..).
5. Person who has possibilities for emerging allergy to cosmetics and/or foods (including experiences of skin irritation by cosmetics within a year).
6. Person who has allergy to adhesive tape and/or medical tape.
7. Person who suffers pollen allergy, rhinitis and atopic dermatitis.
8. Person who is pregnant or lactating, or planned to become pregnant during a test period.
9. Person who participates in the other clinical studies within 4 weeks in the past, or person who scheduled to participate in other clinical studies during the test period.
10. Person who is judged as unsuitable for the study by the investigator for other reasons.
11. Person who herself and/or her family member are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
12. Patient with vascular function disorder, or person who has excessive sensitivity to cold.
13. Person who has abnormal blood pressure or electrocardiogram testing result.
14. Current smoker.
15. Person who experienced medical cosmetic treatment (i.e. cosmetic surgery, collagen injection etc..)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Sugiyama

Organization

Kao Corporation

Division name

R&D Skin Care Products Research

Zip code


Address

5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan

TEL

0465-35-3175

Email

sugiyama.yoshinori@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhito Kazama

Organization

Kao Corporation

Division name

R&D Skin Care Products Research

Zip code


Address

5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan

TEL

0465-35-3175

Homepage URL


Email

kazama.haruhito@kao.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

花王株式会社


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 22 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

No longer recruiting

Date of protocol fixation

2017 Year 03 Month 09 Day

Date of IRB

2017 Year 03 Month 09 Day

Anticipated trial start date

2017 Year 03 Month 23 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 09 Day

Last modified on

2021 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name