UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025667
Receipt number R000029527
Scientific Title A study on the dermatological efficacy of oral administration of beauty capsule
Date of disclosure of the study information 2017/01/18
Last modified on 2017/05/30 08:33:21

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Basic information

Public title

A study on the dermatological efficacy of oral administration of beauty capsule

Acronym

Evaluation of beauty ingredient for skin

Scientific Title

A study on the dermatological efficacy of oral administration of beauty capsule

Scientific Title:Acronym

Evaluation of beauty ingredient for skin

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the dermatological efficacy of beauty capsule for healthy female

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of skin properties, e.g. skin color, transepidermal water loss, and skin hydration and blood parameters before and after capsule intake.

Key secondary outcomes



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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of active capsules twice a day for 8 weeks

Interventions/Control_2

Oral intake of placebo capsules twice a day for 8 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

25 years-old <=

Age-upper limit

49 years-old >=

Gender

Female

Key inclusion criteria

Healthy female suffered from red skin

Key exclusion criteria

-Subjects who go to hospital regularly or went to hospital within the past 1 month for disease: skin, gastrointestinal system, liver, kidney, heart, blood pressure, and physical deconditioning. (Manual therapeutics, chiropractic and massage are not included.)
-Subjects who are routinely taking oral medicine or applying external use medicine (ex. hypnotic, analgesic, anti-histamine, rhinitis drug, hormone preparation, cathartic, intestinal regulator, and others).
-Subjects who have received medical cosmetic treatment before.
-Subjects who have food or drug allergies.
-Subjects who are pregnant, could be pregnant in near future, or are breast feeding.
-Subjects who are participating in another clinical study.
-Subjects who are deemed inappropriate to participate in this study by the principle investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chair

Zip code


Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

TEL

03-5408-1599

Email

jimukyoku@mail.souken-r.com


Public contact

Name of contact person

1st name
Middle name
Last name Ko Masuda

Organization

SOUKEN Co., Ltd

Division name

Management Division

Zip code


Address

3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013

TEL

03-5408-1555

Homepage URL


Email

k_masuda@mail.souken-r.com


Sponsor or person

Institute

SOUKEN Co., Ltd

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

株式会社SOUKEN(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 18 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

2016 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 23 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

2017 Year 01 Month 13 Day

Last modified on

2017 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029527


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name