UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056329 |
|---|---|
| Receipt number | R000064356 |
| Scientific Title | Skin condition improvement evaluation and safty confirmation by application of moisturizing gel "HCDMJ" |
| Date of disclosure of the study information | 2024/12/13 |
| Last modified on | 2024/12/02 12:23:45 |
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Basic information
Public title
Skin condition improvement evaluation and safty confirmation by application of moisturizing gel "HCDMJ"
Acronym
Skin condition improvement evaluation and safty confirmation by application of moisturizing gel "HCDMJ"
Scientific Title
Skin condition improvement evaluation and safty confirmation by application of moisturizing gel "HCDMJ"
Scientific Title:Acronym
Skin condition improvement evaluation and safty confirmation by application of moisturizing gel "HCDMJ"
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate skin condition improvement and to confirm safty by application of moisturizing gel "HCDMJ"
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin moisture content, transepidermal water loss, sebum amount, skin texture, skin viscoelasticity, questionnaire, doctor's fidings at 0-2-4 weeks
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To apply moisturizing gel "HCDMJ" several times a day to both arms
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 years to 59 years old at the time of informed consent
2) Those who can agree not to use body care products other than the test product (including external moisturizing agents such as heparin-like substances) during the test period
3) Those with mild to moderate atopic dermatitis symptoms such as dryness, flakiness, flaking, and peeling on the arms (inner elbows, inner forearms, etc.)
Key exclusion criteria
1) Those who are applying or likely to apply drugs to the test site during the test period
2) Those who have taken steroids or immunosuppressive drugs within one month before the start of the study
3) Those with severe atopic dermatitis or psoriasis
4) Those who may allergic to the test product components
5) Those who regularly use health foods that claim moisturizing effects (ceramides, hyaluronic acid, etc.)
6) Those participating in other clinical trials during the study period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA HEALTHCARE CO., LTD.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064356
