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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029581
Receipt No. R000033691
Scientific Title Efficacy test of the topical agent CIB01
Date of disclosure of the study information 2017/10/20
Last modified on 2018/09/19

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Basic information
Public title Efficacy test of the topical agent CIB01
Acronym Efficacy test of the topical agent CIB01
Scientific Title Efficacy test of the topical agent CIB01
Scientific Title:Acronym Efficacy test of the topical agent CIB01
Region
Japan

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

Objectives
Narrative objectives1 To validate the efficacy of CIB01 in skin and subcutaneous tissue by topical application.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thigh circumference and subcutaneous fat layer thickness at 0, 6 and 12 weeks after the topical application.
Key secondary outcomes

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 Prevention
Type of intervention
Other
Interventions/Control_1 Apply the formulation including an active ingredient to the one side of thigh and the placebo to other side of thigh twice a day 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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria -Subjects who went to a hospital or been received medication for treatment of diseases within the last 1 month.
-Subjects with a history or have been suffered from cardiovascular disease (Such as irregular pulse, angina pectoris, cardiac insufficiency).
-Subjects who are pregnant, planning a pregnancy and lactating.
-Subjects who are more sensitive to soaps, alcohol, velcro, adhesive tape, water-based gel, or permanent marker ink.
-Subjects who underwent liposuction.
-Subjects who had weight change of more than 5 kg within the last 3 months.
-Subjects with atopic dermatitis, contact dermatitis, cutaneous hypersensitivity, any type of skin condition (such as eczema, skin irritation, or skin infection)
-Subjects who participated in another clinical study applying agent or performing tape stripping to test site during this study or within 1 month before this study.
-Subjects who participated in another clinical study eating foods during this study or within 1 month before this study.
-Subjects who recieved special body care treatment for legs such as application of slimming cosmetics, massage by cosmetic instruments and esthetic treatment during this study or within 1 month before this study.
-Subjects who have been suffered from a critical disease.
-Subjects 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 Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7460
Email mori.shinobu@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Erina Maeyama
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7579
Homepage URL
Email maeyama.erina@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 20 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 10 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 20 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 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033691

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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