UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045878 |
|---|---|
| Receipt number | R000052374 |
| Scientific Title | Whitening evaluation study of a test product |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2023/03/23 17:01:55 |
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Basic information
Public title
Whitening evaluation study of a test product
Acronym
Whitening evaluation study of a test product
Scientific Title
Whitening evaluation study of a test product
Scientific Title:Acronym
Whitening evaluation study of a test product
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the preventive effect of pigmentation when the test product is used continuously for 6 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the number of pigmented spots, the skin brightness or melanin amount after continuous use of a test product for 3, 6 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Applying a test product on the face twice a day for 6 weeks.
Interventions/Control_2
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. Aged more than 30 to less than 60 years old.
2. Japanese female
3. Persons who are aware that they have two or more unraised spots on their cheeks
4. Persons who are confirmed to have two or more senile pigmented spots on their cheeks at the time of screening examination.
5. Persons who do not plan to get heavily suntanned or sunburned during the test period.
6. Persons who use "sunscreen" or "sun protection cosmetics" on a daily basis and are able to use them during the test period.
7. Persons who will be exposed to the sun for less than 4 hours on workdays.
8. Persons who can agree to participate in the study voluntarily in writing.
Key exclusion criteria
1. Persons who have scratches or eczema on their face.
2. Persons who have experienced medical cosmetic treatment or are planning during the test period.
3. Persons who have experienced special skincare treatments (beauty salons, esthetic treatments, etc.) within the past 4 weeks or are planning during the test period.
4. Persons who use cosmetics containing whitening ingredients or take medicine or supplements claiming whitening function.
5. Persons who have changed or newly started using supplements, facial cosmetics or sunscreens within the past 4 weeks.
6. Those who have been exposed to UV radiation beyond their daily lives within the last 4 weeks or will be exposed during the test period.
7. Persons who work night shifts or day and night shifts.
8. Persons who are being treated at a medical institution for the treatment or prevention of illness, or those who are judged to be in need of treatment.
9. Persons who have a critical illness related to glucose metabolism, lipid metabolism, liver function, renal function, cardiovascular system, respiratory tract, endocrine system, immune system or nervous system, or have an anamnestic history of psychiatric disorder.
10. Persons with a history of alcohol and drug addiction
11. Persons who may develop allergies to cosmetics and foods
12. Persons who are pregnant, lactating, or wish to become pregnant during the study period
13. Persons who have participated in other human studies within the last 4 weeks, or who are planning to participate in other human studies during the study period.
14. Persons who are overly tanned.
15. Persons who are currently using cream-type skincare products.
16. Persons who work for a cosmetics company or have a family member living with them who works for a cosmetics company.
17. Persons who are judged as unsuitable for the study by the investigator (or the person responsible for this study).
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | |
| Last name | Yoshida |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Healthcare Division
Zip code
5670057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3452-9765
i.yoshida@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Naganuma |
Organization
DRC CO., Ltd.
Division name
Product testing Department
Zip code
530-0044
Address
No9 Tabuchi Building 3F 2-10-31, Higashi tenma, Kita-ku, Osaka
TEL
06-6882-1130
Homepage URL
naganuma@drc-web.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
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
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build 2F, 2-1-2 Shinjyuku, Shinjyuku-ku, 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
| 2021 | Year | 10 | Month | 28 | 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
| 2021 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052374
