UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060059 |
|---|---|
| Receipt number | R000068685 |
| Scientific Title | A Single-Blind, Parallel-Group Interventional Study on the Effects of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium on Skin Dryness and Skin Sensitivity |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/11 22:54:48 |
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Basic information
Public title
A Comparative Application Study of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium on Skin Dryness and Skin Sensitivity
Acronym
A Skin Application Study of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium
Scientific Title
A Single-Blind, Parallel-Group Interventional Study on the Effects of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium on Skin Dryness and Skin Sensitivity
Scientific Title:Acronym
A Single-Blind, Parallel-Group Interventional Study of Human Umbilical Cord-Derived Mesenchymal Stem Cell Conditioned Medium Applied to the Skin of Healthy Volunteers
Region
| Japan |
Condition
Condition
Xerosis and Sensitive Skin
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of the application of human umbilical cord-derived mesenchymal stem cell conditioned medium to the facial skin of healthy volunteers twice daily for three months on skin dryness and skin sensory hypersensitivity (sensitive skin), including pruritus, based on the hypothesis that improvement in skin dryness may alleviate skin sensitivity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measures are transepidermal water loss (TEWL) and stratum corneum hydration of the facial skin.
Key secondary outcomes
The secondary outcome measures are as follows:
(1) Pruritus and skin irritation (e.g., stinging and burning sensations), assessed using a Numerical Rating Scale (NRS).
(2) Wrinkle severity
(3) Skin color (lightness and erythema)
(4) Skin elasticity
(5) Skin permeability
(6) Dermatological findings (presence or absence of eruptions, erythema, and edema), evaluated by a dermatologist.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Application of 0% human umbilical cord-derived mesenchymal stem cell conditioned medium (vehicle only) to the facial skin twice daily after face washing for 3 months.
Interventions/Control_2
Application of 10% human umbilical cord-derived mesenchymal stem cell conditioned medium to the facial skin twice daily after face washing for 3 months.
Interventions/Control_3
Application of 20% human umbilical cord-derived mesenchymal stem cell conditioned medium to the facial skin twice daily after face washing for 3 months.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy females aged between 30 and 59 years
2. Individuals who have never experienced severe sensitive skin or allergic reactions to cosmetics in the past.
3. Individuals who do not have any chronic inflammatory skin diseases.
4. Individuals who, after receiving a sufficient explanation of the study, have fully understood the contents and have provided written informed consent of their own free will.
Key exclusion criteria
1. Individuals who do not meet the inclusion criteria
2. Individuals whom the principal investigator judges to be inappropriate for participation in this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takamori |
Organization
Juntendo University Graduate School of Medicine
Division name
Institute for Environmental and Gender-Specific Medicine
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-City Chiba, Japan Juntendo University Faculty of Medicine, Urayasu Hospital, Building 2, 8th Floor
TEL
047-353-3171
ktakamor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Mitsukoshi |
| Middle name | |
| Last name | Tominaga |
Organization
Juntendo University Graduate School of Medicine
Division name
Institute for Environmental and Gender-Specific Medicine
Zip code
279-0021
Address
2-1-1 Tomioka, Urayasu-City Chiba, Japan Juntendo University Faculty of Medicine, Urayasu Hospital,
TEL
047-353-3171
Homepage URL
tominaga@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Eternam Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1. Department of Dermatology, Juntendo University Urayasu Hospital
2. Eternam Co., Ltd.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
Clinical Research and Trial Center, Juntendo University Hospital, 3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.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
順天堂大学大学院 医学研究科 環境医学研究所 (千葉県)/Institute for Environmental and Gender-Specific Medicine, Juntendo University Graduate School of Medicine (Chiba, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 15 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted at the Institute for Environmental and Gender-Specific Medicine, Juntendo University Graduate School of Medicine, within the Endowed Department of Dermatological Anti-aging and Regenerative Medicine, with financial support from Eternam Co., Ltd.
Management information
Registered date
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068685
