UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019019 |
|---|---|
| Receipt number | R000021943 |
| Scientific Title | Effects of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Females |
| Date of disclosure of the study information | 2015/09/16 |
| Last modified on | 2019/12/23 11:57:29 |
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Basic information
Public title
Effects of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Females
Acronym
Effects of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for Skin Function
Scientific Title
Effects of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for Skin Function of Adult Females
Scientific Title:Acronym
Effects of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for Skin Function
Region
| Japan |
Condition
Condition
Skin Function
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy of Yogurt Drink containing AVGP (Aloe Vera Gel Powder) for skin function of healthy adult females
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Skin viscoelasticity
[2]Transepidermal water loss
[3]Water content of the skin
[4]Collagen score (measuring with ultrasonic waves)
[5]Wrinkles (corner of the eye)
Key secondary outcomes
[1]Observation for skin condition
[2]Subjective symptom for skin condition
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
Oral ingestion of the test product (12 weeks)
Interventions/Control_2
Oral ingestion of the control product (12 weeks)
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy Japanese females aged 30-60 years
Key exclusion criteria
[1]Individuals who use regularly cosmetology or food affecting to skin condition
[2]Individuals who use cosmetics and creams except sunscreen on arm(s)
[3]Individuals whose face and arm(s) have an abnormality requiring treatment
[4]Individuals who contract allergic diseases with sleep deprivation or sleep disorder
[5]Individuals who have skin disease
[6]Individuals who excessively take alcohol
[7]Individuals who is a smoker (smoking over 20 cigarettes/day)
[8]Individuals who contract or have a history of serious skin disease, hepatopathy, kidney damage, heart disease, lung disease, endocrine disease, and metabolic disease
[9] Individuals who have a history of
drug allergy or serious food allergy
[10]Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
[11]Individuals who participate in other clinical studies
[12]Individuals who have chronic constipation (defecation less than 3 times/week) in the past three months
[13]Individuals judged inappropriate for the study by the principal by the results of subject background, physical findings, or medical examination
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Haruhi |
| Middle name | |
| Last name | Sugimura |
Organization
C'est la Vie Shimbashi Clinic
Division name
Medical office
Zip code
105-0003
Address
2-39-3 Nishishimbashi, Minato-ku, Tokyo
TEL
03-5408-8671
h-sugimura@shinkokai.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Dermatology, Wakayama Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
C'est la Vie Shimbashi Clinic Ethics Committee
Address
2-39-3 Nishishimbashi, Minato-ku, Tokyo
Tel
03-5408-8671
h-sugimura@shinkokai.jp
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
| 2015 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 01 | Month | 14 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021943
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
