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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031682
Receipt No. R000029575
Scientific Title Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Date of disclosure of the study information 2018/03/14
Last modified on 2018/06/15

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Basic information
Public title Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Acronym Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Scientific Title Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Scientific Title:Acronym Clinical trials to evaluate the effectiveness of lingonberry and amla fruit extract intake
Region
Japan

Condition
Condition The healthy female who feels decline of the skin condition
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of improving skin condition by the intake of lingonberry and amla fruit extract is evaluated in a randomized, double-blind, placebo-controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The elasticity of the skin is measured four times for 12 weeks every four weeks.
Key secondary outcomes The following measurement item is measured four times for 12 weeks every four weeks.
1. Skin thickness
2. Stratum corneum hydration
3. Epidermal and dermal hydration
4. Clinical evaluation of wrinkle

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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 In the placebo group, the placebo drink must take in every day for 12 weeks.

The placebo beverage is prepared with the same amounts of sweetener, sour seasoning and flavor as test beverage, so that they will not differ in taste from each other.
Interventions/Control_2 The test beverage of "the lingonberry and amla fruit extract (LAE) single dose drink" must take in every day for 12 weeks.
Interventions/Control_3 The test beverage of "LAE double dose drink" must take in every day for 12 weeks.
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
35 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria 1.Healthy females from 35 years old to 50 years old
2.Individuals conscious of skin roughness by drying
3.Individuals who has felt an effect on skin by the intake of the supplement
4.Individuals who feels a decrease of the elasticity of the skin
5. Individuals who does not use a supplement and a drug regularly now
6. Individuals who abstain from drinking alcohol from the day before measurement to the measurement end
7. Individuals who agree to participate in the study
8. Individuals judged appropriate for the study by attendant physician
Key exclusion criteria 1.Individuals with abnormalities of skin areas planned to be tested
2.Individuals considered likely to develop allergy to the test substance (Individuals with food allergy)
3.Individuals with chronic cutis symptoms such as atopic dermatitis
4.Patients receiving drug therapy as outpatients
5.Individuals participating in other studies within the past 3 months
6.Habitual smokers
7.Patients with asthma
8.Pregnant women, women desiring to become pregnant, or lactating women
9.Individuals having used cosmetics or the like possessing moisture-retaining effects on the skin areas planned to be tested in this study within 1 month before the start of the study
10.Individuals taking or intending to take drugs against pollinosis
11.Individuals judged inappropriate for the study by attending physician
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Ogo
Organization SHISEIDO CO., LTD.
Division name Life Science Reserch Center
Zip code
Address 2-2-1,Hayabuchi,Tsuzuki-ku, YOKOHAMA, KANAGAWA-ken 224-0025, Japan
TEL 045-590-6000
Email masashi.ogo@to.shiseido.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Takashima
Organization Inforward, Inc
Division name Ebisu Skin Research Center
Zip code
Address 1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL 03-5447-6411
Homepage URL
Email takashima@inforward.co.jp

Sponsor
Institute SHISEIDO CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 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
2018 Year 03 Month 14 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
2015 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
2016 Year 05 Month 19 Day
Date trial data considered complete
2016 Year 05 Month 20 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 12 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029575

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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