UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030808
Receipt number R000035177
Scientific Title Evaluation of Anti-Wrinkle Products (ID:SME-2017-07-HRCT)
Date of disclosure of the study information 2018/01/21
Last modified on 2018/10/24 15:53:17

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Basic information

Public title

Evaluation of Anti-Wrinkle Products
(ID:SME-2017-07-HRCT)

Acronym

Evaluation of Anti-Wrinkle Products

Scientific Title

Evaluation of Anti-Wrinkle Products
(ID:SME-2017-07-HRCT)

Scientific Title:Acronym

Evaluation of Anti-Wrinkle Products

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of Anti-Wrinkle Products

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of Wrinkle Grade by a doctor

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Application of lotion and cream

Interventions/Control_2

Application of lotion only

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

49 years-old >=

Gender

Female

Key inclusion criteria

1)Age of 20 to 49, female
2)Wrinkle grade of 2 to 4
3)Understanding the study and submitting the written informed consent before the study

Key exclusion criteria

1)User of face cream
2)Subjects with treatment
3)Subjects who are ;
a.With present heart disorder, liver disorder, or kidney disorder, or
b.With history of cardiac disorder, or,
c.With diabetes mellitus, or,
d.With allergy to the study cream or lotion
4)Pregnant or nursing
5)Subjects who are attending other studies or attended other studies within the past 4 seeks,
6)Subjects who are deemed to be unsuitable by the investigator

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Nakamura

Organization

Suntory MONOZUKURI Expert Limited

Division name

HE Center

Zip code


Address

2-3-4 Daiba, Minato-ku, Tokyo

TEL

03-5579-1277

Email

Junichi_Nakamura@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Reiko Izumi

Organization

Suntory MONOZUKURI Expert Limited

Division name

HE Center

Zip code


Address

8-1-1 Seika-dai, Seika-cho, Souraku-gun, Kyoto

TEL

050-3182-0631

Homepage URL


Email

Reiko_Izumi@suntory.co.jp


Sponsor or person

Institute

Suntory MONOZUKURI Expert Limited

Institute

Department

Personal name



Funding Source

Organization

Suntory Wellness Limited

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 01 Month 21 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

2017 Year 12 Month 26 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 22 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

2018 Year 01 Month 15 Day

Last modified on

2018 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035177


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name