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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035885
Receipt No. R000040888
Scientific Title Evaluation of moisturizing effect by intake of Alcocare HG
Date of disclosure of the study information 2020/03/05
Last modified on 2020/08/17

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Basic information
Public title Evaluation of moisturizing effect by intake of Alcocare HG
Acronym Evaluation of moisturizing effect
Scientific Title Evaluation of moisturizing effect by intake of Alcocare HG
Scientific Title:Acronym Evaluation of moisturizing effect
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of moisturizing effect by intake of Alcocare HG
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin moisture content measurement
Key secondary outcomes Skin moisture transpiration measurement
Skin elasticity measurement
Blood test
Skindex-16 (Japanese version)
DLQI
Questionnaire survey

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Test food:night 30min-1h before bedtime
3 capsules/once
Take it with water or lukewarm water once a day, 30min-1h before bedtime.
Interventions/Control_2 Pracebo food:night 30min-1h before bedtime
3 capsules/once
Take it with water or lukewarm water once a day, 30min-1h before bedtime.
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
49 years-old >=
Gender Female
Key inclusion criteria 1) Japanese women aged 30 to 49 years old at the time of acquiring consent
2) Person who are aware of dry skin
Key exclusion criteria 1) During pregnancy or possibly pregnant, or those who are breastfeeding
2) Persons who currently go to dermatology department
3) Persons who may show skin allergic symptoms and persons with skin hypersensitivity
4) Persons participating in other clinical trials
Target sample size 40

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 1050013
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email 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 1050013
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email m_kaneko@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Sanwa Shurui 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
Email 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
2020 Year 03 Month 05 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 40
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
2018 Year 01 Month 18 Day
Date of IRB
2019 Year 01 Month 17 Day
Anticipated trial start date
2019 Year 03 Month 06 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 15 Day
Last modified on
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040888

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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