UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029583 |
|---|---|
| Receipt number | R000033796 |
| Scientific Title | Efficacy test for evaluating the effect of "composition A" on the skin redness. |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2018/10/17 11:36:06 |
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Basic information
Public title
Efficacy test for evaluating the effect of "composition A" on the skin redness.
Acronym
Efficacy test of "composition A" to the skin.
Scientific Title
Efficacy test for evaluating the effect of "composition A" on the skin redness.
Scientific Title:Acronym
Efficacy test of "composition A" to the skin.
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm effect and mechanism of influence on skin redness by "composition A".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin redness induced by ammonia aqueous solution after 3 days third times consecutive 3 hours application (total 9 hours application in a day) of "composition A" and "placebo"
Key secondary outcomes
Stratum corneum components related with skin redness induced by ammonia aqueous solution after 3 days application (third times consecutive 3 hours application, total 9 hours application in a day) of "composition A" and "placebo"
Skin redness induced by ammonia aqueous solution after 3 hours application of "composition A", "placebo" and "composition B".
Amount of "composition A" and "composition B" transferred to skin after 3 hours application of "composition A", "placebo" and "composition B".
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Conduct evaluation 1) to 3) with 2 weeks interval.
1)Wash forearm -> 3 hours application of 3 different concentration of "composition A" and "placebo" -> evaluation of skin redness induced by ammonia aqueous solution.
2)Wash forearm -> 3 hours,3 times,3 days application of 4 different concentration of "composition A" and "placebo". -> evaluation of skin redness induced by ammonia aqueous solution and tape-stripping of stratum corneum.
3)Wash forearm -> 3 hours application of 4 different concentration of "composition A" -> tape-stripping of stratum corneum.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1) 20-49 years old healthy man
2) Men who have healthy and non-troubled skin on their forearm
Key exclusion criteria
-Man who have dermatitis (atopic dermatitis etc.).
-Man under-medication.
-Man who have experience of skin troubled with products containing ammonium aqueous solution.
-Man who is judged as "not eligible" by investigator. For example, man who have sunburned skin, man who have pigmentation, man who have hairy skin, man who have significant skin contour by his mascule and blood vessel.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Ishikawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7473
ishikawa.junko1@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maeko Iwamura |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7443
Homepage URL
iwamura.maeko@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
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 | 10 | Month | 18 | 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 | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033796
