UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050938 |
|---|---|
| Receipt number | R000058058 |
| Scientific Title | A Questionnaire Survey on Skin Problems by Wearing Masks and Validation of the Usefulness of Mask Instruction and Skin Care Instruction |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2025/04/28 00:17:29 |
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Basic information
Public title
A Questionnaire Survey on Skin Problems by Wearing Masks and Validation of the Usefulness of Mask Instruction and Skin Care Instruction
Acronym
A Questionnaire Survey on Skin Problems by Wearing Masks and Validation of the Usefulness of Mask Instruction and Skin Care Instruction
Scientific Title
A Questionnaire Survey on Skin Problems by Wearing Masks and Validation of the Usefulness of Mask Instruction and Skin Care Instruction
Scientific Title:Acronym
A Questionnaire Survey on Skin Problems by Wearing Masks and Validation of the Usefulness of Mask Instruction and Skin Care Instruction
Region
| Japan |
Condition
Condition
Patients who had skin problems caused by masks
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with skin troubles due to masks are increasing because masks are used regularly to prevent new-type corona infections.
The causes of skin trouble caused by masks are various, and it is necessary to carry out mask guidance and skin care guidance considering the existence of skin diseases such as atopic dermatitis and acne vulgaris and the type of mask to be used.
This study
1: Questionnaire on skin problems caused by masks, test
2: Measurement of skin condition when wearing masks by healthy people, test
3: To verify the usefulness of masks guidance and skin care guidance by conducting a questionnaire for patients visiting a dermatologist department.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(7)Endpoint (study 3 endpoint)
a) Safety end point
The duration of use of the test article in all subjects is the same 4 weeks, and changes in skin symptoms are observed at the start of the test and at the end of the test (after 4 weeks).
However, when an adverse event occurs and the drug is discontinued during the study period, the skin condition should be monitored at the end of the study.
At the end of the study (4 weeks later), the investigator will determine the safety of the test article based on the occurrence of adverse reactions in the following 4 steps.
[Safety]
Can be used without adverse reactions, etc.
[Questionable safety].
Drug-related adverse events are unclear.
[Not safe].
The use could not be continued due to side effects.
[Unable to determine]
The results of this test cannot be determined alone.
The objective of this study is to: (1) target a safety endpoint of at least 90% safety assessment.
b) Efficacy end point
The analysis of physiological skin active substances related to the water content of the stratum corneum, transepidermal water transpiration, sebum, inflammation in the stratum corneum, keratinization and skin barrier function before and after the test is carried out.
Key secondary outcomes
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
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Treatment + mask guidance + skin care guidance
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Study 1: Those that wear masks on a daily basis. Gender-neutral.
Study 2: Subjects are employees of TOKIWA Pharmaceutical Co., Ltd. who wish to participate in the study.
Study 3: Subjects who visited Takano Medical Clinic due to skin problems caused by a mask, who were judged by the investigator to be useful for mask guidance and skin care guidance based on their skin findings and interviews, and who wished to participate in the study.
Key exclusion criteria
Study 1:None in particular.
Study 2:In the presence of serious skin disease
Study 3:If you have serious skin disease.As a rule, those who cannot be seen at the end of the study (4 weeks later).In addition, the investigator judges it inappropriate to participate in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mieko |
| Middle name | |
| Last name | Hata |
Organization
Takano Medical Clinic
Division name
Department of Dermatology
Zip code
125-0062
Address
Aoto, Katsushika-ku, Tokyo 6-4-23
TEL
03-3601-2788
yumi_murakami@n1.noevir.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Murakami |
Organization
TOKIWA Pharmaceutical Co., Ltd.
Division name
NOV Academic Research
Zip code
1070062
Address
1-2-6 Minami-aoyama Minato-ku
TEL
08024879414
Homepage URL
yumi_murakami@n1.noevir.co.jp
Sponsor or person
Institute
Takano Medical Clinic
TOKIWA Pharmaceutical Co., Ltd NOV Academic Research
Institute
Department
Personal name
YUMI MURAKAMI
Funding Source
Organization
TOKIWA Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic IRB
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6804-2227
yumi_murakami@n1.noevir.co.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 | 04 | Month | 30 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058058
