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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000036148
Receipt No. 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

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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
Email 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
Email yoshika@yahoo.co.jp

Sponsor
Institute KITASATO UNIVERSITY,SCHOOL OF MEDICINE
DEPARTMENT OF Plastic & Aesthetic Surgery
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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