Unique ID issued by UMIN | UMIN000043385 |
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Receipt number | R000049536 |
Scientific Title | Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis |
Date of disclosure of the study information | 2021/02/19 |
Last modified on | 2021/05/10 13:57:19 |
Safety evaluation of novel bath solution
Safety evaluation of novel bath solution
Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis
Safety evaluation of novel bath solution in patients with atopic dermatitis and xerosis
Japan |
Atopic dermatitis, Xerosis and the like with mild to moderate dry skin symptoms
Dermatology |
Others
NO
To confirm the safety and usefulness of the test bath solution after use for 4 weeks.
Safety
Skin findings(1) and adverse events(2) : dermatologist examination,questionnaire for skin condition and the impression of test bath solution,recording,daily life
(1) 0 week,2 week,4 week
(2) 2 week,4 week
Improvement of dryness and desquamation : dermatologist examination,photographic recording
0 week,2 week,4 week
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Use of the test bath solution at least 5 times a week for 4 weeks
20 | years-old | <= |
69 | years-old | >= |
Male and Female
1. Patients with mild to moderate dry skin symptoms(Atopic dermatitis,Xerosis and the like)
2. Patients with mild to moderate dry skin symptoms at the examination areas
3. Japanese men and women between the ages of 20 and 69
4. Patients giving written informed consent with his or her own will after receiving an adequate information about the test bath solution and aim of this study
1. Patients with rashes at the examination areas that intervene the evaluation
2. Patients with rosacea-like dermatitis or with steroid skin disease
3. Patients who take or anticipate to take medicines that affect the study such as oral steroids, immunosuppresant
4. Patients who have applied medicine or moisturizing agent over the examination areas
5. Patients who have applied cosmetics or quasi-medicine that have moisturizing effect
6. Pregnant women
7. Lactating women
8. Patients who have experienced severe skin symptoms many times due to the use of cosmetics in the past
9. Patients who are judged as inappropriate by principal investigator or sub-investigator with other reasons
40
1st name | Kazuhiko |
Middle name | |
Last name | Takano |
Medical Corporation Hokubukai Utsukushigaoka Hospital
Center for Clinical Pharmacology
004-0839
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
011-882-0111
takano@ughp-cpc.jp
1st name | Takuya |
Middle name | |
Last name | Matsuda |
Medical Corporation Hokubukai Utsukushigaoka Hospital
Center for Clinical Pharmacology
004-0839
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
011-882-0111
matsuda@ughp-cpc.jp
Medical Corporation Hokubukai Utsukushigaoka Hospital
Shiseido Japan Co., Ltd.
Profit organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
011-881-0111
matsuda@ughp-cpc.jp
NO
2021 | Year | 02 | Month | 19 | Day |
Unpublished
Completed
2021 | Year | 02 | Month | 18 | Day |
2021 | Year | 02 | Month | 18 | Day |
2021 | Year | 02 | Month | 22 | Day |
2021 | Year | 04 | Month | 07 | Day |
2021 | Year | 04 | Month | 08 | Day |
2021 | Year | 04 | Month | 15 | Day |
2021 | Year | 04 | Month | 30 | Day |
2021 | Year | 02 | Month | 19 | Day |
2021 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049536
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