UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015327
Receipt number R000017817
Scientific Title A randomized controlled trial for improving effects of test food on skins in women
Date of disclosure of the study information 2014/10/03
Last modified on 2020/10/01 15:39:23

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Basic information

Public title

A randomized controlled trial for improving effects of test food on skins in women

Acronym

A randomized controlled trial for improving effects of test food on skins in women

Scientific Title

A randomized controlled trial for improving effects of test food on skins in women

Scientific Title:Acronym

A randomized controlled trial for improving effects of test food on skins in women

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the test food improves skins in women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Moisture content of the stratum corneum
Skin elasticity

Key secondary outcomes

transepidermal water loss
erythema
total area of wrinkle
skin texture
Analysis of stains, wrinkles, pores, skin color, hidden stains using VISIA
Questionnaires(VAS)


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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material: test food
1 capsules per day (258mg/day)

Interventions/Control_2

Duration: 12 weeks
Test material: Placebo
1 capsules per day (258mg/day)

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

65 years-old >

Gender

Female

Key inclusion criteria

(1)Females aged 30 to 64 years old
(2)Written informed is required

Key exclusion criteria

(1)These prescreened medicine.
(2)These having Food for Specified Health Uses (FOSHU) and/or health food.
(3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., heart, liver, kidney and/or digestive organ).
(4)Pregnant women, lactating women, or women who want to get pregnant during the trial period
(5)Heavy alcohol drinker.
(6)Those that have extremely disheveled lifestyle and/or dietary habits.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who have skin allergy such as the atopy.
(9)Subjects with more than of number of cigarettes smoked an average of 21 per day
(10)Subjects who have been participated in another trial or other investigational and/or enrolled in the other clinical trials within about last 1 month.
(11)Subjects who have treated cosmetic care(e.g., electric facials, esthetic, peeling and/or laser medical treatment).
(12)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
(13)Subjects who have donated over 400 mL of blood and/or blood components within the last four months prior to the current study.
(14)Subjects who collected blood amount of blood sampling over 800 mL within the last twelve months prior to the current study and this clinical trial's blood sampling.
(15)Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Katsuhisa
Middle name
Last name Sakano

Organization

CPCC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Numa

Organization

CPCC Co.,Ltd.

Division name

Plan Sales Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

WAKASA SEIKATSU 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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

Tel

03-2597-5548

Email

IRB@cpcc.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

2014 Year 10 Month 03 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

Completed

Date of protocol fixation

2014 Year 09 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2020 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name