UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035170 |
|---|---|
| Receipt number | R000040086 |
| Scientific Title | A Study on skin improving effects of a pseudo-ceramide containing formulation |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/06/18 17:46:24 |
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Basic information
Public title
A Study on skin improving effects of a pseudo-ceramide containing formulation
Acronym
Evaluation of a pseudo-ceramide containing formulation
Scientific Title
A Study on skin improving effects of a pseudo-ceramide containing formulation
Scientific Title:Acronym
Evaluation of a pseudo-ceramide containing formulation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of a pseudo-ceramide formulation on the skin of healthy females
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the transepidermal water loss,after treatments for 4 weeks use with the pseudo-ceramide containing formulation
Key secondary outcomes
Evaluation of the stratum corneum water content,transepidermal water loss,sebum secretion,skin color,skin viscoelasticity,stratum corneum,dermatological assessment,a questionnaire survey and VAS after treatments for 4 weeks use with the pseudo-ceramide containing formulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the model water based lotion and model lotion on facial skin for twice a day for a week.
And apply the pseudo-ceramide containing formulation and model lotion on facial skin for twice a day for 4 weeks.
Also apply the pseudo-ceramide formulation on legs' skin for twice a day for 4 weeks.
Interventions/Control_2
Apply the model water based lotion and model lotion on facial skin for twice a day for a week.
And apply the water based lotion on the market and model lotion on facial skin for twice a day for 4 weeks.
Also apply the water based lotion on the market on legs' skin for twice a day for 4 weeks.
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy female aged from 20 to 49 years old.
2.Subjects who have sensitive and dry skin consciousness.
3.Subjects who can agree to participate in the study voluntarily in writing.
4.Subjects who can agree to change her currently-using cosmetics to designated ones during the test period.
Key exclusion criteria
1.Subjects who has abnormalities in the skin of the measurement regions
2.Subjects who regularly goes to hospital.
3.Subjects with the anamnesis of an alcohol or a drug dependence.
4.Subjects who regularly use drugs (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc...).
5.Subjects who has possibilities for emerging allergy to cosmetics and/or foods (including experiences of skin irritation by cosmetics within a year).
6.Subjects who has allergy to adhesive tape and/or medical tape.
7.Subjects who suffers pollen allergy, severe rhinitis and atopic dermatitis.
8.Subjects who is pregnant or lactating, or planned to become pregnant during a test period.
9.Subjects who participates in the other clinical studies within 4 weeks in the past, or person who scheduled to participate in other clinical studies during the test period.
10.Subjects who is judged as unsuitable for the study by the investigator for other reasons.
11.Subjects who herself and/or her family members are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
12.Person who experienced medical cosmetic treatments (i.e. cosmetic surgery, collagen injection etc..)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kaizu |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-34-0559
kaizu.kazuhiro@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Watanabe |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-34-0559
Homepage URL
watanabe.daisuke2@kao.com
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（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040086
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