UMIN-ICDS Clinical Trial

Public title

Evaluation of wrinkle improvement

Acronym

Evaluation of wrinkle improvement

Scientific Title

Evaluation of wrinkle improvement

Scientific Title:Acronym

Evaluation of wrinkle improvement

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of wrinkles

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of wrinkle grade
3D analysis of in vivo

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

left-right comparison study
Application of developed product and placebo on each half face

Interventions/Control_2

left-right comparison study
Application of developed product and placebo on each half face

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

60

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Female

Key inclusion criteria

(1)Subjects aged 60 to 79 at the time of informed consent
(2)Subjects who are concerned about wrinkles
(3)Subjects who consent to switch from daily skin items to specified ones
(4)Subjects who spontaneously join the study with written consent after they understand and consent the objective and contents of the study

Key exclusion criteria

(1)Subjects who has factors which can influence the evaluation site (eczema and the like, trauma, acne, tumor, pigmentation, scars, etc.)
(2)Subjects with a history or current history of atopic dermatitis or with a predisposition to atopic dermatitis
(3)Subjects who have undergone or will undergo cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the evaluation area during the examination period
(4)Subjects who have undergone or plan to undergo special skin care procedures (beauty salon, esthetic salon, etc.) on the evaluation site within the past 4 weeks
(5)Subjects who have used medicines (e.g., steroids) as routine skin care for the evaluation site within the past 4 weeks
(6)Subject who has continuously used skin care products, cosmetics, quasi-drugs, or health foods that have efficacy claims similar to or related to the efficacy studied in this study (efficacy against wrinkles and skin whitening)for the evaluated area
(7)Subjects who has changed or started having health foods or using basic cosmetics or sunscreen products for the evaluated area within the past 4 weeks.
(8)Subjects who have been exposed to ultraviolet radiation beyond their daily activities, such as prolonged outdoor work, exercise, swimming, leisure activities, etc., within the past 4 weeks or will be during the study period
(9)Subjects who work night shifts or day/night shifts.
(10)Subjects who have complications and are judged to be poorly controlled by medication or other means, or who are judged to be in need of treatment at the time of consent
(11)Subjects with serious complications or pre-existing medical conditions that make them unsuitable for participation in this study
(12)Subjects with a history of alcohol or drug dependence
(13)Subjects who are at risk of developing allergies to cosmetics (including those who have developed skin problems, such as rashes, with cosmetics within the past year)

Target sample size

40

Name of lead principal investigator

1st name	Hiroyo
Middle name
Last name	Noda

Organization

SUNSTAR Inc.

Division name

R&D

Zip code

658-0032

Address

Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, Japan

TEL

080-9937-4093

Email

hiroyo.noda@jp.sunstar.com

Name of contact person

1st name	Natsuki
Middle name
Last name	Yabumi

Organization

SUNSTAR Inc.

Division name

R&D

Zip code

658-0032

Address

Asia One Center, 8F 1-17, Koyochonaka, Higashinada-ku, Kobe Hyogo, Japan

TEL

080-9937-4102

Homepage URL

Email

natsuki.yabumi@jp.sunstar.com

Institute

SUNSTAR Inc.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Brain Care Clinic Ethics Review Committee

Address

Shiratori Bldg. 2F 2-1-2 Shinjuku, Shinjuku-ku, Tokyo, Japan

Tel

03-4405-1899

Email

info@brain-care-dementia.jp

Secondary IDs

YES

Study ID_1

230112-001

Org. issuing International ID_1

DRC Co., Ltd.

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

03

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

44

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

03

Month

23

Day

Date of IRB

2023

Year

03

Month

23

Day

Anticipated trial start date

2023

Year

03

Month

28

Day

Last follow-up date

2023

Year

06

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

03

Month

27

Day

Last modified on

2023

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057745