UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055080 |
|---|---|
| Receipt number | R000061889 |
| Scientific Title | Human patch test to assess irritation of hair care and skin care products on healthy skin |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/12/05 23:28:13 |
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Basic information
Public title
Human patch test to assess irritation of hair care and skin care products on healthy skin
Acronym
Hair care/skin care patch test research
Scientific Title
Human patch test to assess irritation of hair care and skin care products on healthy skin
Scientific Title:Acronym
Hair care/skin care patch test research
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety and irritation of multiple combinations of commonly used ingredients for cosmetics and quasi-drugs on healthy skin
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patch test positive rate
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Placing combined hair care/skin care products on healthy skin
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
1. 18 years old and older, Japanese
2. Signed informed consent
Key exclusion criteria
1. Currently attending or hospitalized patients with any diseases (including non-dermatological diseases) and/or patients on steroids
2. Pregnant woman or possibly pregnant woman
3. Difficult to perform patch tests on their back with eczema lesions
4. Known history of contact dermatitis with ingredients in the sample of current study
5. Difficult to pursue both 48hrs and 72hrs check-up
6. Sensitive to alcohol
7. Unable to comply with prohibitions during the study
8. Considered by the investigator or any sub-investigator as inappropriate for this study for any reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Tada |
Organization
Teikyo University School of Medicine
Division name
Department of Dermatology
Zip code
1738605
Address
2-1-1 Kaga, Itabashi, Tokyo
TEL
0339641211
tada@df6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Uno |
Organization
Teikyo University
Division name
Academic Research Center
Zip code
173-8605
Address
2-2-2, Kaga, Itabashi, Tokyo
TEL
0339641211
Homepage URL
kiyoko.uno@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA HEALTHCARE CO.
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
Teikyo University Medical Research Ethics Committee
Address
2-1-1 Kaga, ITabashi, Tokyo
Tel
0339641211
kiyoko.uno@med.teikyo-u.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
| 2024 | Year | 07 | Month | 26 | 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 | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061889
