UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050999
Receipt number R000058139
Scientific Title Evaluation of the efficacy and safety of topically applied OC05 cream (221ISC164) in improving wrinkles at the outer corners of the eyes: randomized, single-blind, left-right comparison study.
Date of disclosure of the study information 2023/07/01
Last modified on 2023/05/08 10:47:43

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Basic information

Public title

Evaluation of the efficacy and safety of topically applied OC05 cream in improving wrinkles at the outer corners of the eyes.

Acronym

Evaluation of the efficacy and safety of topically applied OC05 cream in improving wrinkles at the outer corners of the eyes.

Scientific Title

Evaluation of the efficacy and safety of topically applied OC05 cream (221ISC164) in improving wrinkles at the outer corners of the eyes: randomized, single-blind, left-right comparison study.

Scientific Title:Acronym

Evaluation of the efficacy and safety of topically applied OC05 cream (221ISC164) in improving wrinkles at the outer corners of the eyes: randomized, single-blind, left-right comparison study.

Region

Japan


Condition

Condition

Healthy adult female

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of a topical cream applied twice daily for four weeks to improve wrinkles at the outer corners of the eyes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of wrinkle grade in accordance with JCSS guideline

Key secondary outcomes

Water content of stratum corneum
questionnaire
Skin observation by a doctor


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

Prevention

Type of intervention

Other

Interventions/Control_1

The test product, which is dispensed with two pushes, is applied topically twice a day for four weeks.

Interventions/Control_2

The test product, which is dispensed with two pushes, is applied topically twice a day for four 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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

1 Healthy adult females aged 30-60 years.
2 Subjects whose wrinkles at the outer corners of the eyes are judged to be wrinkle grade 2.75-3.75.
3 From the previous paragraphs, subjects with a difference of 0.25 or less between the left and right wrinkle grades will be recruited in the order of the screening test.
4 Subjects with simple skin care habits, such as using only lotion, cream or both
5 Subjects whose written informed consent has been obtained

Key exclusion criteria

1 Subjects with skin conditions that may affect the test results such as urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, or traces of these.
2 Subjects with atopic dermatitis or a past medical history of atopic dermatitis.
3 Subjects who have received or intend to receive aesthetic operations such as Botox, hyaluronic acid or collagen injections, or photofacials during the study period.
4 Subjects who have received or intend to receive skin care treatments at the spa within the last four weeks or during the study period.
5 Subjects who regularly use moisturizers such as cream or all-in-one products and masks, excluding lotion and milky lotion products.
6 Subjects who regularly use cosmetics or ingest foods that are containing vitamin C at the test sites.
7 Subjects who regularly use cosmetics or ingest foods claiming anti-wrinkle efficacy at the test sites.
8 Subjects who have changed or started using a new cosmetic or sunscreen product within the last four weeks.
9 Subjects who have been exposed to ultraviolet light in excess of the dose they could be exposed to on a daily basis, by prolonged outdoor work, exercise, swimming or recreational activities, within the past four weeks, or plan to do so during the test period.
10 Shift workers working on night shifts or rotating day and night shifts.
11 Subjects who are undergoing treatment such as hormone replacement therapy, drug therapy, exercise therapy, diet therapy in a medical institution, or who are diagnosed to require such treatment at the time of obtaining consent.
12 Subjects with past medical history of diseases related to glucose metabolism, lipid metabolism, liver function, renal function, heart function, circulatory system, respiratory system, endocrine system, immune system, nervous system or mental illness.
13 Subjects with a past history of drug or alcohol dependence.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Syota
Middle name
Last name Shimizu

Organization

Otsuka Pharmaceutical Co., Ltd.

Division name

Otsu Skin Care Research Institute

Zip code

520-0002

Address

3-31-13 Saigawa, Otsu, Shiga, Japan

TEL

077-521-8835

Email

Shimizu.Syota@otsuka.jp


Public contact

Name of contact person

1st name Syota
Middle name
Last name Shimizu

Organization

Otsuka Pharmaceutical Co., Ltd.

Division name

Otsu Skin Care Research Institute

Zip code

5200002

Address

3-31-13 Saigawa, Otsu, Shiga, Japan

TEL

0775218835

Homepage URL


Email

Shimizu.Syota@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Brain Care Clinic Ethics Review Committee

Address

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

Tel

06-6882-1130

Email

ethics_board@drc-web.co.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

2023 Year 07 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

18

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

2022 Year 11 Month 10 Day

Date of IRB

2022 Year 11 Month 11 Day

Anticipated trial start date

2022 Year 11 Month 14 Day

Last follow-up date

2022 Year 12 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 05 Month 08 Day

Last modified on

2023 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name