UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023563 |
|---|---|
| Receipt number | R000027134 |
| Scientific Title | Efficacy evaluation test of scalp skin lotion (BSL05-160623K) |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2018/08/01 12:09:28 |
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Basic information
Public title
Efficacy evaluation test of scalp skin lotion (BSL05-160623K)
Acronym
Efficacy of scalp skin lotion
Scientific Title
Efficacy evaluation test of scalp skin lotion (BSL05-160623K)
Scientific Title:Acronym
Efficacy of scalp skin lotion
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Before and after 3, 6 and 9 months from topical application of hair scalp lotion, S100A3 contents, its citrullination, cuticle occupancy and hair elasticity are measured, and evaluated hair damage preventive effect of the lotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Promotion of S100A3 citrullination, and maintainance of S100A3 contents, cuticle occupancy and hair elasticity of the test lotion group compared to the control group, before and after 3, 6 and 9 months from 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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Test lotion on one side of scalp skin and placebo lotion on another side (2mL per each time) are applied two times per a day for six months. Up to 3 months later, the evaluation test continues.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Healthy male and female with standard hair length at temporal regions of head (6cm or more).
-Subject who does not use of products such as a hair restorer, a scalp lotion, and chemical treatment of hair during study duration
-Subject who can record chemical treatments and cuts of hair.
Key exclusion criteria
-Subjects under going to hospital regularly or medication
-Subjects with atopic dermatitis, eczema and pollen allergy or with certain abnormalities in a scalp
-Subjects with advanced hair loss.
-Subject who experienced a certain skin abnormalities or sensitive to a stimulus of the epilation in the past scalp lotion test.
-Subject who is applied or planning non-symmetric hair chemical treatments.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahashi Yoshito |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
5-3-28 Kotobukicho, Odawra, Kanagawa, 250-0002, JAPAN
TEL
0465-34-6116
takahashi.yoshito@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kizawa |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
5-3-28 Kotobukicho, Odawra, Kanagawa, 250-0002, JAPAN
TEL
0465-34-6116
Homepage URL
kizawa.kenji@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
花王株式会社生物科学研究所（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 10 | 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
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027134
| Research Plan | |
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| 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 |
