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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029583
Receipt No. 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

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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
Email 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
Email iwamura.maeko@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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