UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051643 |
|---|---|
| Receipt number | R000058930 |
| Scientific Title | Skin Patch testing of skin and hair care products to the normal volunteer. |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2023/07/19 09:29:22 |
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Basic information
Public title
Skin Patch testing of skin and hair care products to the normal volunteer.
Acronym
Skin Patch testing of skin and hair care products to the normal volunteer.
Scientific Title
Skin Patch testing of skin and hair care products to the normal volunteer.
Scientific Title:Acronym
Skin Patch testing of skin and hair care products to the normal volunteer.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate irritative reaction of new cosmetic products.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patch testing
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Patch testing of 35 samples using fin-chamber for 48 hours on volunteer's back.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
1.Patients who are hospitalized or use steroid ointment.
2.Under the pregnancy
3.Patients who have eczema in their back and a patch test is difficult.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Funasaka |
Organization
Nippon medical school hospital
Division name
Dermatology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyou-ku, Tokyo
TEL
03-3822-2131
funasaka@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saeki |
Organization
Nippon medical school hospital
Division name
Dermatology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyou-ku, Tokyo
TEL
03-3822-2131
Homepage URL
h-saeki@nms.ac.jp
Sponsor or person
Institute
Nippon medical school hospital
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA HEALTHCARE 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
Nippon medical school hospital
Address
1-1-5 Sendagi, Bunkyou-ku, Tokyo
Tel
03-3822-2131
funasaka@nms.ac.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 | 07 | Month | 19 | 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 | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058930
