UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052080 |
|---|---|
| Receipt number | R000058965 |
| Scientific Title | A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy People |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2025/03/03 16:48:21 |
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Basic information
Public title
A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy People
Acronym
A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy People
Scientific Title
A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy People
Scientific Title:Acronym
A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy People
Region
| Japan |
Condition
Condition
Healthy People
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to improve adherence to topical application, quality of skin care, and patient quality of life through "appropriate skin care guidance," and to examine its impact on skin condition using two skin care products with different properties.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Water content in stratum corneum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Skin Care Instruction by Health Care Professionals, Serum cosmetics
Interventions/Control_2
No medical professional skin care instruction, Serum cosmetics
Interventions/Control_3
Skin Care Instruction by Health Care Professionals, Cream cosmetics
Interventions/Control_4
No medical professional skin care instruction, Cream cosmetics
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy women between 30 and 60 years of age (Healthy people are defined as those who do not have drug abuse/dependence, alcohol abuse/dependence, skin, heart, liver, kidney, lung, eye, blood, or digestive system diseases).
(2) A person who is capable of practicing the skin care instructed at home by himself/herself.
(3) The patient must have received a full explanation of his/her participation in this study, and must have given his/her free and voluntary written consent based on full understanding of the study.
Key exclusion criteria
(1) Persons who have experienced contact dermatitis or other skin conditions caused by ingredients of skin care products used in this study or similar ingredients.
(2) Patients with skin rashes or other skin conditions are inappropriate for the area where the skin care product is used.
(3) Patients who cannot be examined after four weeks or eight weeks
(4) Pregnant and lactating mothers
(5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and for whom participation in the study is judged to be difficult.
(6) Those who have not used facial appliances, cosmetic procedures (hyaluronic acid injection, silicon injection, Botox, thread lift, HIFU, etc.) or facial surgery (not to be performed for four weeks prior to the start of the study).
(7) Other persons who are deemed inappropriate as research subjects by the Research Supervisor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Yoshizaki |
Organization
university of tokyo
Division name
Department of Clinical Cannabinoid Research
Zip code
1330057
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
jun.omatsu@gmail.com
Public contact
Name of contact person
| 1st name | jun |
| Middle name | |
| Last name | omatsu |
Organization
The university of tokyo hospital
Division name
dermatology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
jun.omatsu@gmail.com
Sponsor or person
Institute
univesity of tokyo
Institute
Department
Personal name
jun omatsu
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2023 | 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
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 | 07 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058965
