Unique ID issued by UMIN | UMIN000023174 |
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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 |
Use test of makeup cosmetics to the skin disease patient
Use test of makeup cosmetics to the skin disease patient
Use test of makeup cosmetics to the skin disease patient
Use test of makeup cosmetics to the skin disease patient
Japan |
atopic dermatitis
contact dermatitis
acne vulgaris
Dermatology |
Others
NO
To confirm the safety (5 % or less side effects rate) when using 4 weeks makeup cosmetics such as foundation.
Safety
Confirmatory
Explanatory
Not applicable
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.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
1
Treatment
Other |
Make-up cosmetics is replaced with study items.
20 | years-old | <= |
Not applicable |
Female
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".
・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
30
1st name | Makiko |
Middle name | |
Last name | Nakahara |
Kyusyu University
Department of Dermatology, Graduate School of Medical Sciences
812-0054
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
092-642-5596
macky@dermatol.med.kyushu-u.ac.jp
1st name | Makiko |
Middle name | |
Last name | Nakahara |
Kyusyu University Hospital
Dermatology
812-0054
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
092-642-5596
macky@dermatol.med.kyushu-u.ac.jp
Kyusyu University Hospital
Tokiwa Pharmaceutical Co.,Ltd.
Profit organization
Kyusyu University Hospital Certified Review Board
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582 JAPAN
092-642-5774
bynintei@jimu.kyushu-u.ac.jp
NO
2016 | Year | 07 | Month | 15 | Day |
Unpublished
31
Completed
2016 | Year | 07 | Month | 21 | Day |
2016 | Year | 07 | Month | 21 | Day |
2016 | Year | 07 | Month | 22 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 07 | Month | 14 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026714
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