UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

takahashi.yoshito@kao.co.jp

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

Email

katou.arisa@kao.co.jp

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

/Design and Setting
Observation Study of oily and dry facial skin

/Recruiting
Recruiting from Kao USA's panelist database.

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