UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051240 |
|---|---|
| Receipt number | R000058435 |
| Scientific Title | Study on the use of baby sunscreen products in infants with atopic dermatitis |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/09/01 12:11:11 |
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Basic information
Public title
Study on the use of baby sunscreen products in infants with atopic dermatitis
Acronym
Study on the use of baby sunscreen products in infants with atopic dermatitis
Scientific Title
Study on the use of baby sunscreen products in infants with atopic dermatitis
Scientific Title:Acronym
Study on the use of baby sunscreen products in infants with atopic dermatitis
Region
| Japan |
Condition
Condition
Infants from 2 months to under 6 years of age with mild to moderate atopic dermatitis.
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of baby sunscreens after use for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety Assessment / Skin findings,Subjective symptoms and adverse events
Key secondary outcomes
validity assessment / Changes in skin findings and subjective symptoms
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
Use of the test baby sunscreen at least 4 days a week for 4 weeks
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
| 2 | months-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons with mild to moderate atopic dermatitis
2.Infants between 2 months and 6 years of age on the date of obtaining consent prior to the screening test
3.The person must have been fully informed of the purpose and content of the research and must have agreed in writing to participate freely and voluntarily in the research on behalf of the research subject
Key exclusion criteria
1.Patients with rashes at the examination areas that intervene the evaluation
2.Patients with rosacea-like dermatitis or with steroid skin disease
3.Patients who take or anticipate to take medicines that affect the study such as oral steroids, immunosuppresant
4.Patients who have experienced severe skin symptoms many times due to the use of cosmetics in the past
5.Patients who are judged as inappropriate by principal investigator or sub-investigator with other reasons
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Medical Corporation Koujinkai Hiraoka Dermatology Skincare Clinic
Division name
dermatology
Zip code
004-0876
Address
2-2-10, Hiraoka 6jo 2-chome, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-889-1123
hirahifu@road.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sato |
Organization
Clinical Support Corporation Co., Ltd.
Division name
R & D Headquarters Cosmetics Division
Zip code
060-0061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-223-3130
Homepage URL
y-sato@csc-smo.co.jp
Sponsor or person
Institute
Medical Corporation Koujinkai Hiraoka Dermatology Skincare Clinic
Institute
Department
Personal name
Funding Source
Organization
Shiseido Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
matsuda@ughp-cpc.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 | 06 | 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
30
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058435
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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