UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025668 |
|---|---|
| Receipt number | 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 09:24:37 |
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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
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
yamamoto.tetsuji@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029529
