UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035370 |
|---|---|
| Receipt number | R000039480 |
| Scientific Title | Application test of skin care cosmetic mediqol for sensitive skin |
| Date of disclosure of the study information | 2019/01/05 |
| Last modified on | 2019/07/01 08:33:47 |
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Basic information
Public title
Application test of skin care cosmetic mediqol for sensitive skin
Acronym
Application test of skin care cosmetic mediqol for sensitive skin
Scientific Title
Application test of skin care cosmetic mediqol for sensitive skin
Scientific Title:Acronym
Application test of skin care cosmetic mediqol for sensitive skin
Region
| Japan |
Condition
Condition
Moisture retention
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine skin condition when used skin care cosmetic mediqol for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey and observation for skin condition by a doctor (Week 0, Week 2, Week 4)
Key secondary outcomes
Transepidermal water loss, skin moisture/oiliness content, erythema, picture evaluation (Week 0, Week 2, Week 4)
As other indexes : safety
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
Using cosmetic twice a day for 4 consecutive 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals who require moisture retention judged by a doctor
2)Individuals who can visit to clinic (Japanese males or females)
3)Individuals providing written informed consent
4)Individuals not younger than 20 years old at the time of informed consent
Key exclusion criteria
1)Individuals who are sensitive to test product
2)Individuals who are or are possibly pregnant, or are lactating
3)Individuals with severe skin diseases
4)Individuals without capacity to consent
5)Individuals judged inappropriate for the study by a doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Nomura |
Organization
Medical Corporation Soyokazekai, Nomura Dermatology Clinic
Division name
Director
Zip code
221-0825
Address
4-27-14 Tanmachi, Kanagawa-ku, Yokohama, Kanagawa
TEL
045-328-1377
nomunomuhifuka@hotmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nanoegg Research Laboratories, Inc.
Division name
Pharmaceutical Products Research and Development Section
Zip code
210-0821
Address
Innovation Center of NanoMedicine 4F, 3-25-14 Tono-machi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
044-400-1155
Homepage URL
rdm@nanoegg.co.jp
Sponsor or person
Institute
Nanoegg Research Laboratories, Inc.
Institute
Department
Personal name
Funding Source
Organization
Nanoegg Research Laboratories, Inc.
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
IRB
Address
3-4-8 Hatchobori, Chuo-ku, Tokyo
Tel
03-5543-0196
kaneko@smo-msr.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 05 | 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
20
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
| 2018 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039480
| 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 |
