UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050825 |
|---|---|
| Receipt number | R000057922 |
| Scientific Title | Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children. |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/04/12 14:59:10 |
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Basic information
Public title
Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children.
Acronym
Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children.
Scientific Title
Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children.
Scientific Title:Acronym
Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children.
Region
| Japan |
Condition
Condition
two-six years old children
Classification by specialty
| Dermatology | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of safety and usefulness of 70 vol% ethanol emulsified formulation containing olive fruit oil in children.
Basic objectives2
Others
Basic objectives -Others
Safety and usefulness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After using the test product for 4 weeks, "erythema", "scaling/desquamation", "dryness", "hardening/keratinization", "cracks", "disappearance of skin markings", and "pruritus" on palms, backs of hands and fingers. is visually evaluated by a dermatologist to determine safety and usefulness.
Key secondary outcomes
Measurement of skin hydration and transepidermal water loss, stratum corneum evaluation.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the test product at least 4 times a day 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 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Infants with no symptoms of severe inflammation, eczema, atopic dermatitis, etc. at the test site.
(2) The child's guardian agrees to participate in the test.
(3) The child's guardian must be able to fill out usage diaries and questionnaires.
(4) Must be able to come to the clinic on the designated date of visit.
Key exclusion criteria
(1) Those who have a history of allergies to pharmaceuticals, quasi-drugs, or cosmetics, or those who have skin hypersensitivity.
(2) Those who have allergic symptoms to the ingredients of the test product.
(3) Subjects who are taking drugs that may affect the evaluation of this study, such as steroids and immunosuppressants.
(4) Subjects using topical steroids or Protopic on the test site.
(5) Subjects who are using pharmaceuticals, quasi-drugs, and cosmetic hand care external preparations that may affect the usefulness of the test product. However, only petroleum jelly can be used.
(6) Those who are participating in other clinical studies at the start of this study, or those who plan to participate in other clinical studies during the study period.
(7) Those who are judged to be inappropriate by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Goto |
Organization
Sunstar Inc.
Division name
Health & Beauty Innovation R&D
Zip code
658-0032
Address
Asia One Center, 8F, 1-17 koyochonaka, Jigashinada-ku, Kobe,Hyogo, 658-0032, Japan
TEL
+81-80-9937-4110
masashi.goto@jp.sunstar.com
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ayasu |
Organization
Sunstar Inc.
Division name
Health & Beauty Innovation R&D
Zip code
658-0032
Address
Asia One Center, 8F, 1-17 koyochonaka, Jigashinada-ku, Kobe,Hyogo, 658-0032, Japan
TEL
+81-80-9937-4090
Homepage URL
tomomi.ayasu@jp.sunstar.com
Sponsor or person
Institute
Sunstar Inc.
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
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
Validity Evaluation Committee, Sunstar Inc.
Address
Asia One Center, 8F, 1-17 koyochonaka, Jigashinada-ku, Kobe,Hyogo, 658-0032, Japan
Tel
+81-80-9937-4146
kentaro.yamashita@jp.sunstar.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
| 2023 | Year | 04 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2023 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057922
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| Research case data specifications | |
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| Research case data | |
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