UMIN-CTR Clinical Trial

Public title

A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin

Acronym

A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin

Scientific Title

A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin

Scientific Title:Acronym

A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin

Region

North America

Condition

Healthy adults

Classification by specialty

Medicine in general	Dermatology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of the efficacy of a external preparation by analysing gene and protein expression, lipids composition and epidermal structure of skin befor and after 2week application.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of the efficacy of a external preparation by analysing gene and protein expression, lipids composition and epidermal structure of skin befor and after 2week application.

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 need to know

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Topical application of test product to left or right upper arm and control product to the opposite side upper arm for 2 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

30

years-old

<=

Age-upper limit

40

years-old

>=

Gender

Female

Key inclusion criteria

1.Caucasian females, 30 to 40 years of age.
2.Consider themselves to be in general good health.
3.Individuals with normal skin on the upper arms.
4.Individuals willing to have blood drawn for blood serology.
5.Individuals willing to have 4 punch biopsies collected from the upper arms.
6.Individuals willing to refrain from beginning the use of any new skin products on the upper arms for the duration of the study.
7.Individuals who have access to digital cameras or smartphones and are capable of taking pictures of their upper arms after each product application.
8.Willing to provide written informed consent and able to read, speak, write, and understand English.
9.Willing to sign a photography release.
10.Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, AE symptoms, or reactions immediately.

Key exclusion criteria

1.Known allergies to skin care products.
2.Nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
3.A history of skin cancer, having active skin cancer.
4.Diagnosed as having keloid diathesis.
5.A medically diagnosed acute or chronic hepatitis B and hepatitis C.
6.A recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Individuals who have a history of systemic granulomatous diseases, active or inactive, or connective tissue diseases.
7.A health condition and/or pre-existing or dormant dermatologic disease on the upper arms that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
8.Observable suntan, scars, nevi, excessive hair, etc., varicose veins, rashes, compromised, broken skin, scarring, tattoos, or other dermal conditions on the upper forearms that might influence the test results in the opinion of the Investigator or designee.
9.A history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications and/or radiation as determined by study documentation.
10.An uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
11.Any planned surgeries and/or invasive medical procedures during the course of the study.
12.Currently participating in any other clinical trial at Stephens, another research facility or doctor's office or have participated in any clinical trial involving the test area within 4 weeks prior to inclusion into the study at Stephens, at another research facility or doctor's office.

Target sample size

8

Name of lead principal investigator

1st name
Middle name
Last name	Takatoshi Murase

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

0285-68-7871

Email

murase.takatoshi@kao.co.jp

Name of contact person

1st name
Middle name
Last name	Tetsuji Yamamoto

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code

Address

2606, Akabane, Ichikai-machi,

TEL

0285-68-7460

Homepage URL

Email

yamamoto.tetsuji@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

YES

Study ID_1

C16-C193

Org. issuing International ID_1

Thomas J. Stephens & Associates, Inc.

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

コロラド研究センター（米国）

Date of disclosure of the study information

2017

Year

01

Month

16

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

2016

Year

12

Month

14

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

13

Day

Last modified on

2017

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029529