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
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
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
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
