UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023174 |
|---|---|
| Receipt number | R000026714 |
| Scientific Title | Use test of makeup cosmetics to the skin disease patient |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2019/03/31 11:58:06 |
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Basic information
Public title
Use test of makeup cosmetics to the skin disease patient
Acronym
Use test of makeup cosmetics to the skin disease patient
Scientific Title
Use test of makeup cosmetics to the skin disease patient
Scientific Title:Acronym
Use test of makeup cosmetics to the skin disease patient
Region
| Japan |
Condition
Condition
atopic dermatitis
contact dermatitis
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety (5 % or less side effects rate) when using 4 weeks makeup cosmetics such as foundation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
A scoring (pear: 0 points, slight :1 and slightness: 2 points and the degree of middle class: 3 points are serious: 4 points) does the degree of the cutaneous symptom in each observation item of the skin view. When or there are more than 2 items which did more than 1 outbreak when there is more than 1 item which did more than 2 outbreaks before and after a test in a change in the cutaneous symptom by which a doctor in attendance judges that there is causality with this research items, I judge "It has side effects."
Further, when an outbreak of the cutaneous symptom is more than 2 and cause test items can't be specified, study director's judgement and fixation which depends on patch test when object's consent is got, are performed.
Key secondary outcomes
The movement observation, the questionnaire and the QOL investigation by which inspection of safety: is inflammations in the epidermis horny layer and cytokines of a hyperkeratosis, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Make-up cosmetics is replaced with study items.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
More than 20-year-old female with the next one of diseases. I make the person who hopes for make-up to a face the subject.
･Atopic dermatitis
･Contact dermatitis
･Acne
Further, an object makes sure that it's diagnosed as an atopic dermatitis based on definition of an atopic dermatitis "and" criterion of Japanese Dermatological Association and that the stimulator which was diagnosed as a contact dermatitis based on a contact dermatitis medical examination and treatment guideline and caused and an antigen are specified with the person by whom vulgarity za is diagnosed as a rash based on "a vulgarity,za rash treatment guideline".
Key exclusion criteria
･The person who has the experience which has caused the serious cutaneous symptom by use of make-up cosmetics in the past
･Person with the tetter unsuitable for application of the final examination items in an application part
･When intervention of other treatment external preparation and final examination items is expected.
･The person who can't examine it 4 weeks later (as principle)
･Additionally the person by whom a doctor in attendance judges participation in this research with unsuitableness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Nakahara |
Organization
Kyusyu University
Division name
Department of Dermatology, Graduate School of Medical Sciences
Zip code
812-0054
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL
092-642-5596
macky@dermatol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Nakahara |
Organization
Kyusyu University Hospital
Division name
Dermatology
Zip code
812-0054
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
TEL
092-642-5596
Homepage URL
macky@dermatol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyusyu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokiwa Pharmaceutical Co.,Ltd.
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
Kyusyu University Hospital Certified Review Board
Address
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
Tel
092-642-5774
bynintei@jimu.kyushu-u.ac.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
| 2016 | Year | 07 | Month | 15 | 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
31
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 | 07 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026714
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