UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042427 |
|---|---|
| Receipt number | R000048438 |
| Scientific Title | A Study on skin improving effects of a pseudo-ceramide containing formulation for sensitive skin |
| Date of disclosure of the study information | 2020/11/16 |
| Last modified on | 2020/11/12 15:29:25 |
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Basic information
Public title
Evaluation 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 for sensitive skin
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
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of transepidermal water loss, stratum corneum water content and dermatological assessment after treatments for 1 or 2 weeks.
Key secondary outcomes
Evaluation of the skin surface images, questionnaire survey and VAS after treatments for 1 or 2 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the water based model lotion and the model emulsion on facial skin twice a day for a week.
After that, apply the pseudo-ceramide containing formulation in addition to above model lotions and emulsion once a day for 2 weeks.
Interventions/Control_2
Apply the water based model lotion and the model emulsion on facial skin twice a day for three 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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Females who are 20-59 years old
2. Subjects who have sensitive skin consciousness.
3. Subjects who have dry skin consciousness.
4. Subjects who apply to one or more following questions.
a. I need to use skin care products twice a day on my face.
b. Cosmetics and medicines have caused redness, drying and irritation to my skin.
c. I use cosmetic products for sensitive skin.
5. Subjects who use face wash at least 5 days a week
6. Subjects who use lotion or all-in-one cosmetics at least 5 days a week
Key exclusion criteria
1. Subjects who are pregnancy, lactation, or subjects who may become pregnant very soon.
2. Subjects with serious underlying diseases.
3. Subjects who have clear skin symptoms at the test site.
4. Subjects who are currently undergoing hospital treatment with atopic dermatitis
5. Subjects who have had atopic dermatitis symptoms in their face within the present or past year
6. Subjects who are currently treating the skin of the face
7. Subjects who are currently using external drugs (prescription drugs, over-the-counter drugs) on the skin of the face
8. Subjects who are currently participating in product monitor surveys involving testing of the use of other drugs or with the use of quasi-drugs, cosmetics, and facial devices
9. Subjects who are determined to be not appropriate by investigator.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kaizu |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
250-0002
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 | Seri |
| Middle name | |
| Last name | Akiyama |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-34-0559
Homepage URL
akiyama.seri@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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.com
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
株式会社セブンオーワンリサーチ（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 16 | 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
55
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
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048438
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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