UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025590 |
|---|---|
| Receipt number | R000029450 |
| Scientific Title | A Study of the esthetic effect of facial steam treatment |
| Date of disclosure of the study information | 2017/01/22 |
| Last modified on | 2017/07/12 14:13:03 |
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Basic information
Public title
A Study of the esthetic effect of facial steam treatment
Acronym
A study of steam treatment
Scientific Title
A Study of the esthetic effect of facial steam treatment
Scientific Title:Acronym
A study of steam treatment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the esthetic effect of facial steam treatment for healthy females.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of facial skin moisture, facial skin appearance, and relaxation degree at week 0, 2, and 4 of consecutive facial steam treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Applying steam on facial skin for 15 minutes once a day for four weeks.
Interventions/Control_2
No treatment
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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females who are concerned about their facial skin appearance.
Key exclusion criteria
1.Individuals who have some skin troubles and diseases.
2.Individuals who are pregnant or breastfeeding.
3.Current smoker
4.Individuals who have received medical cosmetic treatment on their faces.
5.Individuals who put on eyelash extensions.
6.Individuals who are judged as unsuitable for the study by investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Mizushima |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
03-5630-9580
mizushima.hiroki@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Hosokawa |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
03-5630-9581
Homepage URL
hosokawa.masaru@kao.co.jp
Sponsor or person
Institute
Kao Corporation
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 22 | 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
| 2016 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 23 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029450
