UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048987 |
|---|---|
| Receipt number | R000055807 |
| Scientific Title | Clinical study of whitening cream |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2024/04/02 11:47:14 |
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Basic information
Public title
Clinical study of whitening cream
Acronym
Clinical study of whitening cream
Scientific Title
Clinical study of whitening cream
Scientific Title:Acronym
Clinical study of whitening cream
Region
| Japan |
Condition
Condition
Pigmentation
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of whitening effect and safety on thyroid function through 12 months of continuous use of the test product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual evaluation
Key secondary outcomes
Blood tests (T3, T4, TSH levels)
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test product to the entire face twice a day (morning and night) for 12 months.
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
| 40 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Persons with pigmentation on the face. (melasma, lentigo senilis, ephelis, etc.)
Key exclusion criteria
1. Persons with a smoking habit.
2. Persons with a history of serious illness within the past 5 years.(pigmentation and thyroid function)
3. Persons who currently have thyroid dysfunction.
4. Persons who have received treatment such as immunosuppression within the past 3 months.
5. Persons who may have allergic reactions to cosmetic ingredients.
6. Persons with chronic skin diseases such as atopic dermatitis.
7. Persons at risk of showing hay fever symptoms during the study period.
8. Persons with scars, warts, pimples, permanent makeup, burns, etc. on the face that would affect the evaluation measurement.
9. Persons receiving hormone replacement therapy.
10. Persons who have experience in cosmetic medicine on the face.
11. Persons who have difficulty maintaining lifestyle habits.(eating, exercising, sleeping, skin care, etc.)
12. Persons who are pregnant, lactating, may be pregnant, or wish to become pregnant.
13. Persons who are participating in other clinical study at the start of this study.
14. Individuals or family members who work for a company that develops, manufactures, or sells cosmetics.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Iga |
Organization
Sansho Pharmaceutical Co.,Ltd.
Division name
Raw Material Development Department
Zip code
816-8550
Address
2-26-7,Oike,Onojo-city,Fukuoka
TEL
092-503-1183
iga@dermed.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Iga |
Organization
Sansho Pharmaceutical Co.,Ltd.
Division name
Raw Material Development Department
Zip code
816-8550
Address
2-26-7,Oike,Onojo-city,Fukuoka
TEL
092-503-1183
Homepage URL
iga@dermed.jp
Sponsor or person
Institute
Sansho 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
Tokyo Saiseikai Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Saiseikai Central Hospital Clinical Research Ethics Review Committee
Address
1-4-17 Mita, Minato-ku, Tokyo
Tel
03-3451-8211
tikenjimu@saichu.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
東京都済生会中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | 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
19
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 | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055807
