Unique ID issued by UMIN | UMIN000015335 |
---|---|
Receipt number | R000017830 |
Scientific Title | Clinical study about a skin disorder patient's skin care(2) |
Date of disclosure of the study information | 2014/10/30 |
Last modified on | 2016/10/05 17:04:17 |
Clinical study about a skin disorder patient's skin care(2)
Clinical study about a skin disorder patient's skin care(2)
Clinical study about a skin disorder patient's skin care(2)
Clinical study about a skin disorder patient's skin care(2)
Japan |
A disease patient with atopic dermatitis, psoriasis, old human instinct xerosis, drying of the skin such as contact dermatitides and the pigmentation
Dermatology |
Others
NO
About an unregulated drug developed as a skin care agent for the disease patient with atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and the pigmentation, I carry out a 12-week use examination. For these skin disease patients, I confirm whether you can use this study product without skin stimulation safely and confirm the improvement degree of the dry symptom of the skin as a preliminary evaluation for the usefulness evaluation examination (drying of the skin and improvement of the pigmentation symptom) for the many cases that I will plan in future.
Safety,Efficacy
I do the period of service of this study product in all target people with same 12 weeks and, at the time of a start, observe the change of the skin symptom at the time of six weeks later and the end in (12 weeks later). But, in the case of harmful phenomenon expression, I continue observation until the disappearance of the symptom.
In addition, the desired evaluation in this study aims for a "security" evaluation of more than 90% in Clause 11.2. In addition, as spare examination to the examination in many cases on the basis of the safe confirmation in this study, I pass through a class of corners fluid volume in approximately the examination and analyze an epidermis water loss quantity, skin of epidermis fat quantity, cytokine concerned with inflammation such as class of corners TARC, shape of the class of corners cell and skin color.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
The use part of this study product assumes it face. I list it in an attached sheet document about the usage of each study product (5 preparation) and the instructions. Twice a day (morning, night:) Apply 2 mg/cm2 (with all faces for two pearl grain sizes) to an aim after bathing in), all faces and a neck; for the significant part of the pigmentation more study product (Clause 0.4:) I apply knob lift white whitening stick). In addition, I do not set it during the wash out period in approximately the examination.
20 | years-old | <= |
Not applicable |
Female
Among the patients with the symptom of drying of the skin and the pigmentation, I intend for a person meeting the next standard.
・Atopic dermatitis, psoriasis, senile xerosis, drying of the skin such as contact dermatitides and pigmentation
The person who is judged from the person of the disease with the symptom in the treatment of the underlying disease if the use of this study product is useful
・The person who is stable in its symptom of the underlying disease by treatment
・Woman 20 years or older
・The person that a written agreement is provided from the person
In the case of next, I exclude it from an object.
・Person with the experience that produced the skin symptoms such as contact dermatitides by this study product ingredient and similar ingredient
・Person with the exanthem that is unsuitable for the application of this study product in the application part
・The person who is not stable in its symptom of the underlying disease
・A man and woman younger than 20 years
・The person whom (as a general rule) cannot examine 12 weeks later
・Person of pregnancy and nursing
・In addition, the person that an examination responsibility (allotment) doctor judges the participation in this study to be inappropriate
20
1st name | |
Middle name | |
Last name | Katsuko Kikuchi |
Tohoku University Graduate School of Medicine.
Department of Dermatology
1-1seiryo-cho aoba-ku sendai
022-717-7271
kkikuchi@med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Katsuko Kikuchi |
Tohoku University Graduate School of Medicine.
Department of Dermatology
1-1seiryo-cho aoba-ku sendai
022-717-7271
kkikuchi@med.tohoku.ac.jp
Department of Dermatology
Tohoku University Graduate School of Medicine.
TOKIWA Pharmaceutical Co., Ltd.
Profit organization
NO
2014 | Year | 10 | Month | 30 | Day |
Unpublished
Completed
2014 | Year | 11 | Month | 30 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 09 | Month | 16 | Day |
2014 | Year | 10 | Month | 03 | Day |
2016 | Year | 10 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017830
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |