UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029581 |
|---|---|
| Receipt number | 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 15:18:03 |
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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
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
maeyama.erina@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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033691
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
