UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036428 |
|---|---|
| Receipt number | R000041499 |
| Scientific Title | A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application. |
| Date of disclosure of the study information | 2019/04/10 |
| Last modified on | 2019/10/08 10:00:15 |
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Basic information
Public title
A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Acronym
A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Scientific Title
A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Scientific Title:Acronym
A Preliminary Study of an Anti-Wrinkle Product for a 12-Week Application.
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine an effect of an anti-wrinkle product for a 12-week application and its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Indexes for evaluating skin condition (doctor's questions and assessment of skin condition(1), photo evaluation(1), skin quality evaluation(1), wrinkle topography(2)).
(1)Screening, Week 0, Week 4, Week 8, Week 12.
(2)Week 0, Week 4, Week 8, Week 12.
Key secondary outcomes
[1]Questionnaires about skin condition (Week 0, Week 4, Week 8, Week 12).
[2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Other |
Interventions/Control_1
Applying test products (applying test product A [right face] vs applying test product B [left face]).
Interventions/Control_2
Applying test products (applying test product B [right face] vs applying test product A [left face]).
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
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
[1]Japanese female aged 35-55 years.
[2]Individuals whose wrinkle grade is 3.0 -5.0*.
[3]Individuals whose do not apply cosmetics and cuasi-drugs for anti-wrinkle.
[4]Individuals who apply 1-3 products for skin care after washing.
[5]Individuals who can stop drinking alcohol during the test period.
[6]Individuals whose written informed consent has been obtained.
*Task Force Committee for Evaluation of Anti-aging Function. Guideline for Evaluation of Anti-wrinkle Products. Journal of Japanese Cosmetic Science Society, 30(4): 316-332, 2006.
Key exclusion criteria
[1]Individuals with chronic skin disease, such as atopic dermatitis.
[2]Individuals with strange skin conditions at measurement points.
[3]Individuals who had been conducted an operation on the test spot.
[4]Individuals who is a patient of hay fever and take a drug.
[5]Individuals who were took a special facial treatment in the past 1 month.
[6]Individuals who have a habit to ingest supplements claiming for brightening effect.
[7]Individuals who cannot avoid daylight exposure during the test period.
[8]Individuals who had ingested health-promoting foods, foods for specified health uses, health foods, or supplements being effective for the study.
[9]Individuals who have a history of serious heart disease, kidney damage, and endocrine disease.
[10]Individuals who conduct or have conducted hormone replacement therapy for menopausal disorder.
[11]Individuals who take tabaco or alcohol regularly or whose eating habit is irregularity.
[12]Subjects who are pregnant or breast-feeding.
[13]Individuals judged inappropriate for the trial by the principal.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nemoto |
Organization
Medical Corporation Kojinkai
Division name
Chief Director
Zip code
064-0807
Address
2-1-4 Minami Nanajo Nishi, Chuo-ku, Sapporo 0640807, JAPAN
TEL
+81-11-221-8807
sapporo@kojinkai.org
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
Derma Labo, Inc.
Institute
Department
Personal name
Funding Source
Organization
LG Household & Health Care Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Republic of Korea
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015 JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.co.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
| 2019 | Year | 04 | Month | 10 | 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
20
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
| 2019 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 04 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041499
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