UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054108 |
|---|---|
| Receipt number | R000060764 |
| Scientific Title | Research on the anti-pigmentation effect of a new combination of whitening ingredients in humans |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/04/10 17:12:30 |
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Basic information
Public title
Research on the whitening effect of a combination of whitening ingredients
Acronym
Research on the whitening effect
Scientific Title
Research on the anti-pigmentation effect of a new combination of whitening ingredients in humans
Scientific Title:Acronym
Research on the anti-pigmentation effect of whitening ingredients in humans
Region
| Japan |
Condition
Condition
Whitening
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regarding the effect of suppressing melanin production due to ultraviolet irradiation, an in vivo test using human forearm skin showed that when niacinamide and L-ascorbic acid 2-glucoside were used in combination, the efficacy and effect of the single agent were different. Make comparisons. In addition, it should be confirmed that the whitening effect falls within the category of quasi-drugs when niacinamide and L-ascorbic acid 2-glucoside are used in combination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of pigmentation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application to human skin
Interventions/Control_2
Application to human skin
Interventions/Control_3
Application to human skin
Interventions/Control_4
Application to human skin
Interventions/Control_5
Application to human skin
Interventions/Control_6
Application to human skin
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
We will be recruiting test participants internally. As a requirement for participation, we will recruit those who have self-diagnosed and have no abnormalities in the inner part of their forearm, which is the test site.The test director will confirm the condition of the applicant's inner part of the forearm, and then decide whether or not to participate. do. For those who are determined to be able to participate, consent will be explained as follows.
Key exclusion criteria
Those who meet the following conditions that may have an impact on this research will be excluded.
(1) Conditions on the skin of the test site (inner forearm) that may affect the test results (cuts, abrasions, diseases such as hives, inflammation, eczema, acne, warts, spots, etc.) or traces of it)
(2) People with photosensitivity who can easily develop painful swelling and blisters even when exposed to a small amount of ultraviolet light.
(3) Persons with a past or present history of atopic dermatitis or those with atopic factors
(4) Those who are taking the following medicines.
Drugs that suppress inflammation
Adrenal corticosteroids, antiallergic agents, antihistamines, etc.
Drugs and health foods that cause photosensitivity
Antibacterial agents, diuretics, antihypertensive agents, antibiotics, chlorella foods, etc. for the treatment of infections.
Vitamin C-based drug preparations, vitamin EC-based drug preparations, SH-based drug preparations, and tranexamic acid-containing preparations, etc.
(5) Those who regularly use whitening products, sunscreen cream, etc. on the test area
(6) Those with a history of photosensitivity or photoallergy
(7) Those who have been exposed to ultraviolet rays in the past 4 weeks beyond their normal daily activities, such as working outdoors for long periods of time, exercising, swimming at the beach, or having leisure activities. Or those who have plans to do so during the exam period.
(8) Those who are at risk of developing allergies to cosmetics or food.
(9) Those who are participating in other human clinical research (all human trials using quasi-drugs, cosmetics, foods, pharmaceuticals, medical devices, etc.) on the day consent was obtained, or who are conducting this research. Those who plan to participate in other human clinical research during the scheduled period
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yohsuke |
| Middle name | |
| Last name | Hada |
Organization
Technoble Co., Ltd.
Division name
Life Science General Institute
Zip code
550-0015
Address
1-26-24, Minamihorie, Nishi-ku, Osaka
TEL
06-6532-9741
hada@technoble.co.jp
Public contact
Name of contact person
| 1st name | Yohsuke |
| Middle name | |
| Last name | Hada |
Organization
Technoble Co., Ltd.
Division name
Life Science General Institute
Zip code
550-0015
Address
1-26-24, Minamihorie, Nishi-ku, Osaka
TEL
06-6532-9741
Homepage URL
hada@technoble.co.jp
Sponsor or person
Institute
Technoble Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Technoble 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
Nara Medical University
Address
840 Shijo-Cho, Kashihara, Nara, Japan
Tel
0744-25-7657
ino_rinri@naramed-u.ac.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
| 2024 | Year | 12 | Month | 31 | 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
9
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
| 2023 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060764
