UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020287 |
|---|---|
| Receipt number | R000023426 |
| Scientific Title | Observational Study on Oily and Dry Facial Skin |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2016/05/11 14:35:30 |
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Basic information
Public title
Observational Study on Oily and Dry Facial Skin
Acronym
Observational Study on Oily and Dry Facial Skin
Scientific Title
Observational Study on Oily and Dry Facial Skin
Scientific Title:Acronym
Observational Study on Oily and Dry Facial Skin
Region
| North America |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding about the combination of oily and dry facial skin through the observations
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the amount of sebum secretion, sebum composition, gene expressions, protein expressions, skin flora, skin color, dermatological assessment and skin moisture content
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Panelists who are female and Caucasian with their ages from 18 to 45 years old. Panelists with normal or combined oily and dry facial skin according to their self-assessments
2.Panelists who are willing to avoid sun exposure, tanning beds, sunless tanners, and skin lightening products on their faces from the day two weeks prior to the study to the day when the study completes.
3.Panelists who agree to follow their typical daily routines and refrain from starting any new activities while participating in the study (e.g. swimming, tanning bed usage, exercising, sunbathing).
4.Panelists who agree to follow their typical facial care routines and agree not to switch or try any new facial products or make-ups from the day two weeks prior to the study to the day when the study completes.
5.Panelists who agree to refrain from using any supplements OTC or prescription medications, especially for sebum regulation, anti-bacteria, and anti-inflammation from the day two weeks prior to the study to the day when the study completes.
6.Panelists who are willing to wash their faces not to apply any cosmetics at the night before each lab visit and refrain from applying any facial moisturizers, facial products, or make-ups on their faces at the morning immediately before the lab visits.
7.Panelists who agree to participate in the study after understanding the possible risks and benefits during this study and signing the informed consent form.
8.Panelists who are willing to have photographs and measurements taken on their faces.
9.Panelists who are willing to attend the repetitive two days.
Key exclusion criteria
1.Panelists who have very or extremely sensitive skins on their faces. Panelists who have a known allergy or sensitivity to any facial care product, facial cleanser, or to any specific ingredient or fragrance used in these types of products
2.Panelists having illnesses or diseases which, in the opinion of the investigator, might interfere with the conduct of the study or the interpretation of results. Panelists with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their faces
3.Panelists who take a prescription or OTC medication which, in the opinion of the investigator, might interfere with the conduct of the study or the interpretation of results.
4.Panelists who have used a topical or oral antibiotic on their faces in the last two weeks.
5.Panelists under the care of a doctor or dermatologist for facial skin issues or taking prescription medication (topical or oral) for any facial skin issues.
6.Panelists who have started any types of estrogen or hormone therapies (including birth control pills) within four weeks prior to the study implementation and/or are planning to start aforementioned therapies during the study. Panelists who are pregnant or breastfeeding or are planning to be pregnant.
7.Panelists who have undergone a sort of chemical peeling on their faces in the last six months.
8.Panelists who have undergone a sort of laser therapy on their faces in the last six months.
9.Panelists currently participating in, or scheduled to participate in, another facial study during the study period.
10.Panelists who have used a pore strip on their faces within two weeks prior to the study implementation.
11.Panelists who work for, or have household members who work for, a manufacturer or an advertiser of personal care products.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Takahashi |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
5-3-28, Kotobuki-machi, Odawara-shi, 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 | Arisa Kato |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7498
Homepage URL
katou.arisa@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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 21 | 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
| 2015 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
/Design and Setting
Observation Study of oily and dry facial skin
/Recruiting
Recruiting from Kao USA's panelist database.
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023426
