UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062781 |
|---|---|
| Receipt number | R000071871 |
| Scientific Title | Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 11:22:24 |
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Basic information
Public title
Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment
Acronym
Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment
Scientific Title
Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment
Scientific Title:Acronym
Exploratory Study of Skin Condition When Using Face Masks After Aesthetic Treatment
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to examine the safety, changes in skin condition, and impact on user experience associated with the use of face masks following Aesthetic Treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of the test cosmetic: safety assessment, adverse events, and side effects
Skin findings: visual assessment and photographic assessment by a physician
Key secondary outcomes
Skin condition scores based on VISIA facial image analysis
Scores based on Aura facial image analysis
Subjective symptom questionnaire
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
Use a face mask once immediately after the treatment, and then use one once every night for two weeks starting from the day of the treatment.
Interventions/Control_2
Apply Petrolatum once immediately after the treatment, and then use one once every night for two weeks starting from the day of the treatment.
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 years or older at the time of obtaining consent
(2) Individuals undergoing the cosmetic procedure targeted by this study
(3) Individuals capable of completing documents such as consent forms and questionnaires
(4) Individuals who have received a full explanation regarding the study's purpose and content, possess the capacity to consent, have a clear understanding of the study, have voluntarily applied to participate, and have provided written consent to participate
Key exclusion criteria
(1) Individuals whom the principal investigator or study physician deems to have a significant difference in skin condition between the left and right sides of the face
(2) Individuals who have undergone cosmetic procedures, such as laser therapy, light therapy, or radiofrequency treatment, within one month prior to the start of the study
(3) Individuals planning to undergo facial cosmetic medical procedures other than the procedure targeted by this study during the study period
(4) Individuals with a history of allergies to cosmetics or to ingredients contained in the test product(including individuals who developed contact dermatitis caused by cosmetics within one year prior to the start of the study)
(5) Individuals likely to be exposed to excessive ultraviolet radiation during the study period
(6) Individuals who are pregnant or breastfeeding at the time of consent, or who wish to become pregnant during the study period
(7) Individuals who have participated in another human clinical trial within one month prior to the start of the study, or who plan to participate in one during the study period
(8) Individuals otherwise deemed unsuitable for participation in the study by the principal investigator or study physician
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 | Yuki |
| Middle name | |
| Last name | Azuma |
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
Homepage URL
hsrpd@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd.
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
Sacred Heart Beauty Clinic Atami Branch
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Noguchi Dermatology Clinic, Medical Corporation Hakureikai
Address
964-1 Kamishima, Kashima-machi, Kamimashiki-gun, Kumamoto Prefecture,861-3106,JAPAN
Tel
096-237-4112
info@nogcli.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
| 2026 | Year | 09 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071871
