UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020338 |
|---|---|
| Receipt number | R000023490 |
| Scientific Title | Efficacy test of the moisturizer SIR |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2016/05/06 14:42:59 |
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Basic information
Public title
Efficacy test of the moisturizer SIR
Acronym
Efficacy test of the moisturizer SIR
Scientific Title
Efficacy test of the moisturizer SIR
Scientific Title:Acronym
Efficacy test of the moisturizer SIR
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of water content, transepidermal water loss, visual score and texture after the topical application for 4 and 8weeks
Key secondary outcomes
Change of cell morphology and the composition of stratum corneum after the topical application for 4 and 8 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the formulation including an active ingredient to the half of facial skin twice daily for 8 weeks
Apply the placebo formulation to the half of facial skin twice daily for 8 weeksApply the formulation including an active ingredient to the one lower leg twice daily for 8 weeks
Apply the placebo formulation to the one lower leg twice daily for 8 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
-Subjects with cutaneous symptoms of atopic dermatitis
-Pregnancies and lactations
-Subjects undergoing hormon therapy
-Subjects participation in another clinical study accompanied by topical application of formulations and tape stripping or delipidation treatment to obtain experimental dry skin to the sites to be studied within the past 1 month
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiyoshi Katsumata |
Organization
EXAM CO., LTD
Division name
Cosmetic Laboratory Department
Zip code
Address
H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-0001, JAPAN
TEL
011-205-0781
dermalabo@ekusamu.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiyoshi Katsumata |
Organization
EXAM CO., LTD
Division name
Cosmetic Laboratory Department
Zip code
Address
H.O/2. Nishi 5-chome, Kita-1-jo, Chuo-ku, Sapporo, Hokkaido, 060-001, JAPAN
TEL
011-205-0781
Homepage URL
dermalabo@ekusamu.co.jp
Sponsor or person
Institute
EXAM CO., LTD
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
株式会社エクサム デルマラボ（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 25 | 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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023490
