UMIN-CTR Clinical Trial

Public title

A study to see the dermatological efficacy of XXXXI on healthy skin

Acronym

A study to see the dermatological efficacy of XXXXI on healthy skin

Scientific Title

A study to see the dermatological efficacy of XXXXI on healthy skin

Scientific Title:Acronym

A study to see the dermatological efficacy of XXXXI on healthy skin

Region

North America

Condition

Healthy adults

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of the efficacy of XXXXI on the sebum secretion of healthy females.
XXXXI is the code name of the material.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

valuation of the sebum content, the sebum composition, the gene expressions, the skin flora, the skin color and the dermatological assessment before the application of XXXXI and after the application of XXXXI for 4 and 6 weeks

Key secondary outcomes

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply Sample to the face skin twice daily for 6 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

Age-lower limit

18

years-old

<=

Age-upper limit

45

years-old

>=

Gender

Female

Key inclusion criteria

1_Panelists who are females, ages 18-45, Caucasians and African Americans.
2_Panelists who possess a sufficient amount of sebum.
3_Panelists who are willing to avoid sun exposure, tanning beds, sunless tanners, and skin lightening products until the study completes.
4_Panelists who agree to follow their typical daily routine and refrain from starting any new activities (e.g. swimming, tanning bed usage, exercising, sunbathing, etc.).
5_Panelists who are willing to use only the provided test products in place of their own personal facial cleansers, facial moisturizers, and facial pore strips for the duration of the study.
6_Panelists are allowed to continue using their own personal cosmetic/make-up items (foundation, eye-shadow, mascara, etc.).
7_Panelists who agree to refrain from the use of any their own personal cosmetic/make-up items, especially for sebum regulation, anti-bacterial, and anti-inflammation.
8_Panelists who agree to refrain from the use of any supplements, OTC or prescription medications, especially for sebum regulation, anti-bacterial, and anti-inflammation.
9_Panelists who are willing to wash their faces at the night before each lab visit and refrain from applying any facial moisturizers, facial products, or make-up on their faces prior to the lab visits.
10_Panelists who are willing to have photographs and measurements taken on their faces.

Key exclusion criteria

1_Panelists who have a known allergy or sensitivity to any facial care product, facial moisturizer, facial cleanser, pore strip, 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.
Especially panelists with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their face.
3_Panelists who take OTC or prescription medications 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 antibiotic on their faces in the last two weeks.
5_Panelists under the care of a doctor or dermatologist taking prescription medication (topical or oral) for any facial skin issues.
6_Panelists who have started any type of estrogen or hormone therapy including birth control pills in the last four weeks and/or are planning to start them during the study.
Panelists who are pregnant, planning to be pregnant, or breastfeeding
7_Panelists who have used pore strips on their faces in the
last two weeks.
8_Panelists who have undergone chemical peeling on their faces in the last six months.
9_Panelists who have undergone laser therapy, or phototherapy on their faces in the last six months.
10_Panelists currently participating in, or scheduled to participate in, another facial study during the study period.
11_Panelists who work for, or have household members who work for, a manufacturer or advertiser of personal care products.

Target sample size

30

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-tyou, 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 Katou

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

None

Organization

Division

Category of Funding Organization

Self funding

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

Spring Grove Laboratories(KY, USA)

Date of disclosure of the study information

2015

Year

10

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

09

Month

15

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

21

Day

Last modified on

2015

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022494