UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022287 |
|---|---|
| Receipt number | R000025582 |
| Scientific Title | The Effect of Skin Lotion on Drying of Skin (A Four Week Trial) |
| Date of disclosure of the study information | 2016/05/12 |
| Last modified on | 2016/12/02 09:24:34 |
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Basic information
Public title
The Effect of Skin Lotion on Drying of Skin (A Four Week Trial)
Acronym
The Effect of Skin Lotion on Drying of Skin
Scientific Title
The Effect of Skin Lotion on Drying of Skin (A Four Week Trial)
Scientific Title:Acronym
The Effect of Skin Lotion on Drying of Skin
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effect of 4-week usage of the test product on the skin condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Skin moisture content (preliminary observation, Week 4)
[2]Transepidermal water loss (preliminary observation, Week 4)
Key secondary outcomes
[1]Sebum capacity (preliminary observation, Week 4)
[2]Skin pH (preliminary observation, Week 4)
[3]Visual evaluation by a medical specialist/ physician's interview (preliminary observation, Week 4)
[4]Horny layer analysis(preliminary observation, Week 4)
[5]Subjective questionnaire (preliminary observation, Week 4)
[6]Subject's diary (From the first day of using a test material to the last day of the test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Applying a test product A (on the left-half of the face; 1ml/day [twice a day]; 4 weeks)
Interventions/Control_2
Applying a test product B (on the right-half of the face; 1ml/day [twice a day]; 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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Japanese males and females aged 30-49 years
[2]Individuals who are healthy and have no chronic physical disease including skin disease
[3]Individuals who are worry about drying of skin
[4]Individuals who apply basic skin-care products with a way of the following patterns
a)unused
b)only lotion
c)lotion + milky liquid
d)lotion + beauty liquid
[5]Individuals who can change a lotion being used to a test product
[6]Individuals whose written informed consent has been obtained
[7]Individuals who can have an examination in a designated day
[8]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals with skin disease, such as atopic dermatitis
[3]Individuals with strange skin conditions at measurement points
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month
[5]Individuals who changed or will change skin care products during the test period in the past 2 months
[6]Individuals who have a history of applying steroidal anti-inflammatory agent for treatment of skin disease in the past 6 months
[7]Individuals who are sensitive to cosmetics
[8]Individuals who would emerge seasonal allergy and use drugs (except eye drops and nose drops)
[9]Individuals who used cosmetics or drugs improving skin moisture or tension at measurement points in the past 3 months
[10]Individuals who treated or will treat cosmetics or drugs claiming chemical peeling on measurement points in the past 3 months
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period
[12]Individuals who cannot avoid daylight exposure during the test period
[13]Individuals who had an operation at measurement point in the past 6 months
[14]Individuals who have an addiction to alcohol or a mental illness
[15]Individuals whose life style will change during the test period
[16]Individuals who participate or will participate in other clinical studies
[17]Individuals who participated in other clinical studies in the past three months
[18]Individuals who are or are possibly pregnant, or are lactating
[19]Individuals judged inappropriate for the study by the principal
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Nakata |
Organization
Medical Corporation Bokushinkai CLINTEXE Clinic
Division name
Director
Zip code
Address
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL
03-5405-1059
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd
Division name
Department of Clinical Trial
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
03-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 12 | 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 | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 15 | 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 | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025582
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| Registered date | File name |
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