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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025668
Receipt No. R000029529
Scientific Title A study of dermatological efficacy after continuous application of topical product (CDM050) in human skin
Date of disclosure of the study information 2017/01/16
Last modified on 2017/04/04

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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