UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036148 |
|---|---|
| Receipt number | R000039976 |
| Scientific Title | Study on the effect of skin recovery assistance after treatment such as wound on cosmetic base "Face collagen" manufactured by Face Inc. |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2019/05/13 17:41:59 |
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Basic information
Public title
Study on the effect of skin recovery assistance after treatment such as wound on cosmetic base "Face collagen" manufactured by Face Inc.
Acronym
Study on the effect of skin recovery assistance after treatment such as wound on cosmetic base "Face collagen" manufactured by Face Inc.
Scientific Title
Study on the effect of skin recovery assistance after treatment such as wound on cosmetic base "Face collagen" manufactured by Face Inc.
Scientific Title:Acronym
Study on the effect of skin recovery assistance after treatment such as wound on cosmetic base "Face collagen"
Region
| Japan |
Condition
Condition
Kitasato University Hospital Department of Orthopedic and Cosmetic Surgery, Patients who were judged as blemishes and bruises, Q switch ruby laser therapy was performed.
A person having a test site that can distinguish between the test article and the comparison object (placebo).
Those who can go to hospital for 3 months even after treatment with medicine is finished.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using cosmetics using facial half-side test (double-blind method), observe morphology of skin findings / measure skin moisture content, analyze wrinkle / wrinkle of skin by digital camera image, conduct questionnaire on subjects to be studied By doing so, we aim to observe effect by applying cosmetic products.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 ,skin finding 2, measurement of skin moisture content 3, analysis of wrinkle and wrinkle of skin by digital camera image 4, Study subject questionnaire
A, Skin findings /Measurement of skin moisture content/ Digital camera shooting is performed six times in total, before treatment, before application of the test article, 2 weeks after, 4 weeks after, 8 weeks after, 12 weeks after
B, The questionnaire for the subjects to be studied will be conducted three times in total, 4 weeks after, 8 weeks after, 12 weeks after application start
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The specimen and the comparative product are started to be coated after the epithelial recovery.
Interventions/Control_2
Subjects apply 5-6 drops (one centimeter in palm size) per test twice daily in the morning and night as the test article designated at the designated site.
Interventions/Control_3
The period shall be 12 weeks after the start of application
Interventions/Control_4
Only use specified cosmetics during the test period. (Makeup supplies are not limited.) The use of the test article is cleansed and done immediately after towel drying.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Kitasato University Hospital Department of Plastic and aesthetic Surgery, Patient diagnosed as blemishes, patient with Q switch ruby laser therapy.A patient having a test site that can selectively use the test article and the comparative sample.Those who can go to hospital for 3 months even after treatment with medicine is finished
Key exclusion criteria
1. People who have an allergy to cosmetics 2. Those receiving hormone replacement therapy
3.Those pregnant or lactating
4.Those who have experiences of cosmetic care that will affect the site to be examined or who are planned to receive it during the examination period
5.Those who have received special skin care treatment (beauty salon, esthetics etc) for the examination site within the past 4 weeks or planned during the examination period
6.Those who have inflammation or skin disease other than the treatment on the test site or who developed it.
7.Subjects that Professor Takeda considers inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takeda |
Organization
Kitasato University,school of medicine
Division name
DEPARTMENT OF Plastic & Aesthetic Surgery
Zip code
252-0374
Address
1-15-1Kitasato,Minami-ku,Sagamihara-city,Kanaagawa
TEL
042-778-9074
takeda@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Sugimoto |
Organization
KITASATO UNIVERSITY,SCHOOL OF MEDICINE
Division name
DEPARTMENT OF Plastic & Aesthetic Surgery
Zip code
252-0374
Address
1-15-1Kitasato,Minami-ku,Sagamihara-city,Kanaagawa
TEL
042-778-9074
Homepage URL
yoshika@yahoo.co.jp
Sponsor or person
Institute
KITASATO UNIVERSITY,SCHOOL OF MEDICINE
DEPARTMENT OF Plastic & Aesthetic Surgery
Institute
Department
Personal name
Funding Source
Organization
FAITH 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
Kitasato university,school of Medicine Department of Plastic and Aesthetic Surgery
Address
1-15-1Kitasato,Minami-ku,Sagamihara-city,Kanaagawa
Tel
0427789074
yoshika@yahoo.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
| 2019 | Year | 03 | Month | 11 | 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
35
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
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As I found an incomplete content of the research plan prior to the research implementation,After making a new research plan,It was decided that the ethics committee approves again and UMIN's approval.
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
