UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019994
Receipt No. R000022715
Scientific Title Efficacy test of the moisturizer JI1
Date of disclosure of the study information 2015/11/30
Last modified on 2016/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy test of the moisturizer JI1
Acronym Efficacy test of the moisturizer JI1
Scientific Title Efficacy test of the moisturizer JI1
Scientific Title:Acronym Efficacy test of the moisturizer JI1
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of water content, transepidermal water loss, visual score and texture after the topical application for 4, 8, 12 weeks
Key secondary outcomes Change of cell morphology and the composition of stratum corneum after the topical application for 4, 8, 12 weeks

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 Apply the formulation including an active ingredient to the half of facial skin twice daily for 12 weeks
Apply the placebo formulation to the another half of facial skin twice daily for 12 weeks
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
35 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria -Subjects with cutaneous symptoms of atopic dermatitis

-Pregnancies and lactations

-Subjects undergoing hormon therapy

-Subjects participation in another clinical study accompanied by topical application of formulations and tape stripping or delipidation treatment to obtain experimantal dry skin to the sites to be studied within the past 1 month

-Subjects deemed inappropriate to participate in this study by the parinciple investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiyoshi Katsumata
Organization EXAM CO., LTD
Division name Cosmetic Laboratory Department
Zip code
Address H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-001, JAPAN
TEL 011-205-0781
Email dermalabo@ekusamu.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiyoshi Katsumata
Organization EXAM CO., LTD
Division name Cosmetic Laboratory Department
Zip code
Address H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-001, JAPAN
TEL 011-205-0781
Homepage URL
Email dermalabo@ekusamu.co.jp

Sponsor
Institute EXAM CO.,LTD
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 株式会社エクサムデルマラボ事業部(北海道)         

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 30 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
2015 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 24 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
2015 Year 11 Month 30 Day
Last modified on
2016 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.