UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060588 |
|---|---|
| Receipt number | R000068867 |
| Scientific Title | Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/05 13:21:38 |
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Basic information
Public title
Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents
Acronym
Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents
Scientific Title
Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents
Scientific Title:Acronym
Use Test of Sunscreen Products (Cosmetics) for Children with Dry Skin Symptoms and Their Parents
Region
| Japan |
Condition
Condition
photosensitivity, atopic dermatitis, infantile xerotic eczema, infantile eczema
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As research on the effects of sunlight, particularly ultraviolet (UV) radiation, on the human body advances, awareness of the necessity for UV protection is also growing. For individuals with skin conditions, UV radiation can be a factor worsening symptoms, making UV countermeasures crucial. In this study, newly developed sunscreen products (cosmetics) will be used by children with skin conditions such as photosensitivity, atopic dermatitis, infantile xerotic eczema, and infantile eczema, along with their guardians.By providing appropriate guidance on sunscreen use to parents, we aim to deepen their understanding of UV protection, improve treatment adherence, and ensure proper application to children. We will confirm the safety and efficacy of the product, including whether it can be used without issue as part of daily skincare and whether it exacerbates skin symptoms in children or their parents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study doctor will conduct examinations at the start ,after two weeks, and at the end of the trial (4 weeks later), including assessment of skin findings, photography, and questionnaire surveys.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The study doctor selects the test product to be used from among the test samples (six types of sunscreen agents) based on the required level of light-blocking effectiveness and the action wavelength (UVB, UVA, visible light) for each disease, as well as the characteristics of the test product (such as light-blocking effect and user experience).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Children diagnosed with photosensitivity, atopic dermatitis, infantile xerotic eczema, or infantile eczema, for whom the use of this investigational drug is deemed therapeutically beneficial, and their parents.
Key exclusion criteria
(I)Individuals with a history of severe skin reactions caused by sunscreen use
(II)Individuals with rashes or other conditions on the application site that make application of the test product inappropriate
(III)Cases where interference between the test product and other topical treatments is anticipated
(IV)Individuals who, in principle, cannot attend a follow-up examination 2 weeks later or at the end of the trial (4 weeks later)
(V)Individuals deemed unsuitable for participation in this study by the study physician
Target sample size
80
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
1250062
Address
6-4-23 Aoto, Katsushika-ku, Tokyo
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
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
New Takano Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic Research Ethics Committee
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6455-4173
cns_jimu@triad-j.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
| 2026 | Year | 02 | Month | 05 | 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
| 2006 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 05 | 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 | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068867
