UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028964 |
|---|---|
| Receipt number | R000033146 |
| Scientific Title | A study on efficacy of HB35FA against UV-induced skin inflammation. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2019/12/20 12:14:19 |
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Basic information
Public title
A study on efficacy of HB35FA against UV-induced skin inflammation.
Acronym
Evaluation of beauty ingredient for skin
Scientific Title
A study on efficacy of HB35FA against UV-induced skin inflammation.
Scientific Title:Acronym
Evaluation of beauty ingredient for skin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-inflammatory effect of HB35FA against UV-induced skin inflammation for healthy male
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Evaluation of anti-inflammatory effect after 3 weeks of HB35FA administration.
Key secondary outcomes
-Change of inflammatory markers in the stratum corneum after 3 weeks of HB35FA administration.
-Change of fecal microbiome and metabolome after 4 weeks of HB35FA administration.
-Change of blood inflammatory markers after 4 weeks of HB35FA administration.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
-Oral administration of an active drink every day for 4 weeks.
-A 4-week washout period.
-Oral administration of a placebo drink every day for 4 weeks.
Interventions/Control_2
-Oral administration of a placebo drink every day for 4 weeks.
-A 4-week washout period.
-Oral administration of an active drink every day for 4 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
-Subjects with photosensitive dermatitis.
-Subjects with clinically-significant disorder at the test site
-Subjects who go to hospital regularly or routinely taking oral medicine for disease: gastrointestinal system, liver, kidney, heart, and blood pressure.
-Subjects who are routinely taking oral medicine for sunburn, chloasma, and freckles.
-Subjects who are deemed inappropriate to participate in this study by the principle investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinobu Mori |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7460
mori.shinobu@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kuwano |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7459
Homepage URL
kuwano.tetsuya@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033146
