UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041544 |
|---|---|
| Receipt number | R000047341 |
| Scientific Title | The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/08/29 07:41:49 |
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Basic information
Public title
The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Acronym
The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Scientific Title
The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Scientific Title:Acronym
The clinical evaluation of topical nanoencapsulation retinol combination cosemtic for wrinkles of the skin
Region
| Japan |
Condition
Condition
Severe wrinkles around eyes
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study of effect for wrinkles around eyes when used topical nanoencapsulation retinol combination cosmetic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire and observation for skin condition on before study starting and 4 weeks and 8 weeks after study starting
Key secondary outcomes
Investigating of VISIA, skin viscoelasticity, TEWL, erythema, water content in the corneal layer, and replica of wrinkles around eyes on before study starting and 4 weeks and 8 weeks after study starting
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of the test cosmetic A to the one side of the face,
Application of the test cosmetic B to the another side of the face,
8 weeks, twice a day
Interventions/Control_2
Application of the test cosmetic C to the one side of the face,
Application of the test cosmetic D to the another side of the face,
8 weeks, twice a day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 6 to 7 wrincle grade in eye area
2) Individuals who can visit to clinic (Japanese males and females)
3) Individuals providing written informed consent
4) Individuals not younger than 20 years old at the time of informed consent
Key exclusion criteria
1) Individuals who are sensitive to test product
2) Individuals who are or are possibly pregnant, or are lactating
3) Individuals with severe skin diseases
4) Individuals without capacity to consent
5) Individuals judged inappropriate for the study by a doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nanoegg Research Laboratories, Inc.
Division name
Pharmaceutical Products Research and Development Section
Zip code
210-0821
Address
Innovation Center of NanoMedicine 4F, 3-2514 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
044-400-1155
rdm@nanoegg.co.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kubota |
Organization
Nanoegg Research Laboratories, Inc.
Division name
Pharmaceutical Products Research and Development Section
Zip code
210-0821
Address
Innovation Center of NanoMedicine 4F, 3-2514 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
044-400-1155
Homepage URL
rdm@nanoegg.co.jp
Sponsor or person
Institute
Nanoegg Research Laboratories, Inc.
Institute
Department
Personal name
Funding Source
Organization
Nanoegg Research Laboratories, Inc.
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
Institutional Review Board for the Asai Dermatology Clinic
Address
RBM Kyobashi building, 3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel
03-5543-0196
aya.onoda@smo-msr.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
医療法人社団美翔会 聖心美容クリニック 熱海院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | 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
1
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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047341
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| Registered date | File name |
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