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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027272
Receipt No. R000031246
Scientific Title A study on the effect of the different bases on topical dosage in adult volunteers.
Date of disclosure of the study information 2017/05/11
Last modified on 2019/04/22

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Basic information
Public title A study on the effect of the different bases on topical dosage in adult volunteers.
Acronym A study on the effect of the different bases on topical dosage in adult volunteers.
Scientific Title A study on the effect of the different bases on topical dosage in adult volunteers.
Scientific Title:Acronym A study on the effect of the different bases on topical dosage in adult volunteers.
Region
Japan

Condition
Condition Not applicable.
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of the different bases on topical dosage in adult volunteers.
Basic objectives2 Others
Basic objectives -Others Not applicable.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ・Topical dosage for four days.
Key secondary outcomes ・Skin friction, skin elasticity.
・Personal evaluation on topical use.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Topical application in the order of oinment,cream,lotion.
Interventions/Control_2 Topical application in the order of oinment,lotion,cream.
Interventions/Control_3 Topical application in the order of cream,oinment,lotion.
Interventions/Control_4 Topical application in the order of cream,lotion,oinment.
Interventions/Control_5 Topical application in the order of lotion,oinment,cream.
Interventions/Control_6 Topical application in the order of lotion,cream,oinment.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1)The person who is 20 to 64 years old.
Key exclusion criteria (1)The person who has a skin disease during treatment in the forearm
(2)The person who has an abnormal finding such as eczema,dermatitis,inflammation caused by the sunburn, wound and scar in the forearm.
(3)The person who has a excessive gorwth of hair inside of the forearm.
(4)The person who has/had a sensitivity with topical drug or cosmetics.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuki
Middle name
Last name Yamashita
Organization Nikoderm Research Inc.
Division name Evaluation Division
Zip code 541-0052
Address 1-6-14 Azuchimachi,Chuoku,Osaka,Japan
TEL 06-6125-3501
Email yamashita@nikoderm.com

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Yamashita
Organization Nikoderm Research Inc.
Division name Evaluation Division
Zip code 541-0052
Address 1-6-14 Azuchimachi,Chuoku,Osaka,Japan
TEL 06-6125-3501
Homepage URL
Email yamashita@nikoderm.com

Sponsor
Institute Maruho Co.LTD.
Clinical Development Division
Institute
Department

Funding Source
Organization Maruho Co.LTD.
Clinical Development Division
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 Institutional Review Board about the study for people.
Address Nakano-Shinbashi-Plaza building F7 703 2-20-8 Yayoi-cho, Nakano-ku, Tokyo 100-8968, Japan
Tel 03-5354-5959
Email info@toukastress.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 株式会社ニコダームリサーチ(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 11 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 02 Month 14 Day
Date of IRB
2017 Year 03 Month 30 Day
Anticipated trial start date
2017 Year 05 Month 11 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 07 Month 09 Day
Date analysis concluded
2018 Year 09 Month 11 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 08 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031246

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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