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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034004 |
Receipt No. | R000038769 |
Scientific Title | Whitening effect of the supplement and cosmetics when used alone compared to simultaneously |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2019/02/01 |
Basic information | ||
Public title | Whitening effect of the supplement and cosmetics when used alone compared to simultaneously | |
Acronym | Whitening effect of the supplement and cosmetics when used alone compared to simultaneously | |
Scientific Title | Whitening effect of the supplement and cosmetics when used alone compared to simultaneously | |
Scientific Title:Acronym | Whitening effect of the supplement and cosmetics when used alone compared to simultaneously | |
Region |
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Condition | |||
Condition | Healthy person | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the whitening effect of the test cosmetics and test foods when used alone and simultaneously. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Skin color quantification by spectrophotometer
Skin color evaluation by skin color scale |
Key secondary outcomes | VISIA image analysis
Questionnaire |
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 | 3 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Test food (Intake priod:12 weeks) | ||
Interventions/Control_2 | Test cosmetics (use priod:12 weeks) | ||
Interventions/Control_3 | Test food and Test cosmetics (use priod:12 weeks) | ||
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1)Japanese healthy females aged 35 to 54 years at the time of informed consent.
2)Healthy subjects who do not have chronic physical disorders,including skin diseases. 3)Subjects who have senile pigment freckle on face. 4)Subjects who agree to participate in the study on one's own will. 5)Subjects who can visit the designated medical institution on specified date during the study. 6)Subjects who are judged as reasonable participants for the study by the doctor in charg. |
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Key exclusion criteria | 1)Subjects who have certain diseases and undergoing drug treatment on medication.
2)Subjects who are currently using medication. 3)Subjects who have taken medicines for the purpose of treating diseases within the past one month. 4)Subjects who are suffering or suffered from serious disease. 5)Subject who have skin disease. 6)Subjects who have sensitive skin. 7)Subjects who have severe skin disorders on the face. 8)Subjects who have mole, acne vulgaris, erythema, capillary dilation at the measurement points. 9)Subjects who have may show allergic symptoms to cosmetics. 10)Subjects who may show severe allergic symptoms to the test foods. 11)Subjects who have alcoholism or other psychiatric disorders. 12)Subjects who have smoking habit. 13)Subjects who may change lifestyle habits during the test period. 14)Subjects who are unable to refrain from direct sunlight, during the test period. 15)Subjects who develop pollinosis and may use medication during the study period. 16)Subjects who used or will use of medications, health foods, supplements, which have skin whitening and skin improvement effects during the test period, or who have used any of the above within the past 3 months. 17)Subjects who used cosmetics or medication that may advocate the whitening effect within the past 3 months or who are planning to use them during the test period. 18)Subjects who had treatment history at the evaluation site within the past 6 months. 19)Subjects who are pregnant or breast-feeding. 20)Subjects who are participating in other clinical studies or who have participated in other clinical studies within the past 3 months. 21)Subjects who or whose family work for a company that develops, manufactures or sells health foods, and cosmetics. 22)Subjects who are judged as unsuitable participant for the study by the doctor and the investigator in charge for other reasons. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | FANCL Corporation | ||||||
Division name | Research Institute, Health science research center | ||||||
Zip code | |||||||
Address | 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa | ||||||
TEL | 045-820-3755 | ||||||
ke-yui@fancl.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | TES Holdings Co., Ltd | ||||||
Division name | Administrative Department of Clinical Trials | ||||||
Zip code | |||||||
Address | 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN | ||||||
TEL | +81-3-6801-8480 | ||||||
Homepage URL | |||||||
r.shimizu@tes-h.co.jp |
Sponsor | |
Institute | FANCL Corporation |
Institute | |
Department |
Funding Source | |
Organization | FANCL Corporation |
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 | |
Address | |
Tel | |
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 | うえのあさがおクリニック(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038769 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |