UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052728 |
|---|---|
| Receipt number | R000060156 |
| Scientific Title | Effects of euglena cosmetic ingredients for Skin Conditions |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2023/11/08 10:39:27 |
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Basic information
Public title
Effects of euglena cosmetic ingredients for Skin Conditions
Acronym
Effects of euglena cosmetic ingredients for Skin Conditions
Scientific Title
Effects of euglena cosmetic ingredients for Skin Conditions
Scientific Title:Acronym
Effects of euglena cosmetic ingredients for Skin Conditions
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate if skin condition improves with single and repeated application of euglena cosmetic ingredients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal Water Loss
Stratum Corneum Moisture
Sebum
Melanin
Skin Viscoelasticity
VISIA Imaging Evaluation
Key secondary outcomes
Subjective Skin Evaluation Criteria
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics (oil) to the designated left or right half face during 1 month.
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women aged 20 to 64.
2.Individuals who practice simple skin care routines after cleansing.
3.Those who have concerns with dry skin.
4.Participants who do not typically develop hay fever during the trial period.
5.Individuals with no history of allergic reactions to cosmetics.
6.Those who can visit the designated facility on the scheduled trial dates.
7.Participants who can strictly adhere to the designated trial product usage conditions.
8.Subjects whose written informed consent has been obtained
Key exclusion criteria
1.Individuals with a history of skin diseases.
2.Those who are pregnant or breastfeeding.
3.Individuals currently taking or applying medications that may affect the results of the trial.
4.Those who have received cosmetic medical treatments within 4 weeks prior to the start of the trial.
5.Individuals who have undergone skin care treatments within 4 weeks prior to the start of the trial.
6.Those with extensive acne, wounds, warts, or similar issues on the area where the product is to be applied, making them unsuitable as subjects.
7.Others whom the trial's principal investigator deems inappropriate for the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka,
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Nakashima |
Organization
Euglena Co.,Ltd.
Division name
Lifescience Research Institute
Zip code
2300045
Address
1-6 Suehirocho, Tsurumi Ward, Yokohama City, Kanagawa Prefecture
TEL
03-3453-4907
Homepage URL
nakashima@euglena.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Euglena Co.,Ltd.
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
Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka,
Tel
06-6135-5200
mterashima@miura-cl.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
| 2024 | Year | 11 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 13 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060156
