UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031748
Receipt number R000036150
Scientific Title Influence on skin condition when juice and cosmetics are used in combination
Date of disclosure of the study information 2018/03/16
Last modified on 2020/03/16 10:37:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Influence on skin condition when juice and cosmetics are used in combination

Acronym

Influence on skin condition when juice and cosmetics are used in combination

Scientific Title

Influence on skin condition when juice and cosmetics are used in combination

Scientific Title:Acronym

Influence on skin condition when juice and cosmetics are used in combination

Region

Japan


Condition

Condition

Healthy adult female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Divide healthy women into three groups and compare between groups.
One group drinks Seabuckthorn's juice, the second group drinks of Seabuckthorn's juice and cosmetics are used, and the third group is nonintervention.
Continue ingestion for 4 weeks, compare and evaluate the effects on the skin when used.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin condition, comparison of intergroup and intragroup

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food Other

Interventions/Control_1

Seabuckthorn's juice drinking and three types of cosmetic use continue for 4 weeks each

Interventions/Control_2

Continue drinking Seabuckthorn's juice for 4 weeks

Interventions/Control_3

not intervention

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

59 years-old >=

Gender

Female

Key inclusion criteria

1. Subjects whose wrinkle class in the outer corner is 1 to 3
2. Subjects with cheeks and face line slack

Key exclusion criteria

1. Subjects with cosmetic allergies
2. Subjects with food allergies
3. Subjects who are pregnant or lactating
4. Subjects who are judged as unsuitable for the study by the investigator for the other reason

Target sample size

21


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatomo Najima

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Email

info@yakujihou.org


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Kaneko

Organization

Japan Clinical Trial Association

Division name

N.A.

Zip code


Address

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

TEL

0364574666

Homepage URL


Email

info@yakujihou.org


Sponsor or person

Institute

Japan Clinical Trial Association

Institute

Department

Personal name



Funding Source

Organization

Takarajima Japan 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

2018 Year 03 Month 16 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

2018 Year 03 Month 15 Day

Date of IRB

2018 Year 02 Month 15 Day

Anticipated trial start date

2018 Year 03 Month 16 Day

Last follow-up date

2018 Year 04 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 15 Day

Last modified on

2020 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036150


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name