UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin
Title of the study (Brief title)	A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin
Region	North America

Condition
Condition	Healthy adults
Classification by specialty	Medicine in general Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7871
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	Tetsuji Yamamoto
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi,
TEL	0285-68-7460
Homepage URL
Email	yamamoto.tetsuji@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

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)

Secondary IDs
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
Institutions	コロラド研究センター（米国）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 13 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029529