UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037870
Receipt number R000043133
Scientific Title Study on effects of placenta intake on skin characteristics
Date of disclosure of the study information 2019/11/01
Last modified on 2021/03/02 12:32:41

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Basic information

Public title

Effects of placenta intake on skin conditions

Acronym

Effects of placenta on skin

Scientific Title

Study on effects of placenta intake on skin characteristics

Scientific Title:Acronym

Effects of placenta on skin characteristics

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effects of placenta intake on the skin characteristics such as degree of multiple layered cells and water or oil content.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Degree of multiple layered keratinocytes, water content. oil content, and water transpiration quantity of skin.
(Before the intake, and 2, 4, and 6 weeks after the onset of placenta intake)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Subjects intake 8 tablets of commercial placenta supplements (equivalent to porcine placenta extract 200 mg) daily for 6 weeks.

Interventions/Control_2

Subjects intake 8 tablets of placebo daily for 6 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

20 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy men and women with no skin diseases such as atopic dermatitis

Key exclusion criteria

Persons with skin diseases such as atopic dermatitis

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Niwa

Organization

Tokyo University of Agriculture

Division name

Department of Food, Aroma and Cosmetics, Faculty of Bioindustry

Zip code

099-2493

Address

196 Yasaka, Abashiri, Hokkaido

TEL

0152-48-3841

Email

k3niwa@nodai.ac.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Niwa

Organization

Tokyo University of Agriculture

Division name

Department of Food, Aroma and Cosmetics, Faculty of Bioindustry

Zip code

099-2493

Address

196 Yasaka, Abashiri, Hokkaido

TEL

0152-48-3841

Homepage URL


Email

k3niwa@nodai.ac.jp


Sponsor or person

Institute

Tokyo University of Agriculture

Institute

Department

Personal name



Funding Source

Organization

DHC 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

Research Institute, Tokyo University of Agriculture

Address

1-1-1, Sakuraoka, Setagaya, Tokyo

Tel

03-5477-2532

Email

nri@nodai.ac.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 11 Month 01 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

2019 Year 10 Month 01 Day

Date of IRB

2019 Year 10 Month 01 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2021 Year 03 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

2019 Year 08 Month 31 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043133


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name