UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061129 |
|---|---|
| Receipt number | R000069937 |
| Scientific Title | Evaluation of Skin Condition Changes Following Face sheet Mask Use After Cosmetic Medical Procedures |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/04/01 15:08:02 |
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Basic information
Public title
Evaluation of Skin Condition Changes Following Face sheet Mask Use After Cosmetic Medical Procedures
Acronym
Evaluation of Skin Condition Changes Following Face sheet Mask Use After Cosmetic Medical Procedures
Scientific Title
Evaluation of Skin Condition Changes Following Face sheet Mask Use After Cosmetic Medical Procedures
Scientific Title:Acronym
Evaluation of Skin Condition Changes Following Face sheet Mask Use After Cosmetic Medical Procedures
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of sheet mask application on skin condition post-cosmetic medical procedures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of skin conditions
1) VISIA facial imaging Analysis
2) Trans-epidermal water loss
3) Stratum corneum moisture content
4) Mexameter score
Key secondary outcomes
Subject self-assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will apply a facial sheet mask immediately after treatment, followed by seven additional applications over a 28-day period according to a predefined schedule
Interventions/Control_2
Apply Petrolatum immediately after the treatment, followed for seven additional applications over a 28-day period according to a predefined schedule
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 or older at the time of obtaining consent.
2) Individuals who wish to undergo laser treatment.
3) Individuals who have received a full explanation of the purpose and content of the research, have the capacity to give consent, fully understand the information, voluntarily volunteer to participate, and provide written consent to participate in the research.
Key exclusion criteria
1) Individuals whom the principal investigator has determined to have differences in skin condition between the left and right sides of their face.
2) Individuals who plan to undergo cosmetic medical procedures on their face other than those covered by this study during the study period.
3) Individuals at risk of developing an allergic reaction to cosmetics or to ingredients contained in the test products used in this study.
4) Individuals who are pregnant or breastfeeding at the time of consent, or who wish to become pregnant during the study period.
5) Individuals who have participated in another human study within the past four weeks, or who plan to participate in another human study during the period of participation in this study.
6)Any other individuals deemed unsuitable for participation in the study by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Takahashi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science & Data Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
hsrpd@rohto.co.jp
Public contact
Name of contact person
| 1st name | Sindhu |
| Middle name | |
| Last name | Thangavel |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
New Business Development Division/ Rohto Science Hub Tokyo, Tokyo Skin Lab
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, 105-0022
TEL
03-6832-6013
Homepage URL
hsrpd@rohto.co.jp
Sponsor or person
Institute
Shin-Kawasaki Eve Clinic for Dermatology and Aesthetic Medicine
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
rinri@s-palace-clinic.com
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
| 2026 | Year | 04 | Month | 02 | 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
| 2026 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069937
