Unique ID issued by UMIN | UMIN000021795 |
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Receipt number | R000025133 |
Scientific Title | Study of the utility of BPO products for acne vulgaris on trunk (back and chest) |
Date of disclosure of the study information | 2016/04/10 |
Last modified on | 2018/10/17 09:26:25 |
Study of the utility of BPO products for acne vulgaris on trunk (back and chest)
Study of the utility of BPO products for acne vulgaris on trunk
Study of the utility of BPO products for acne vulgaris on trunk (back and chest)
Study of the utility of BPO products for acne vulgaris on trunk
Japan |
Acne vulgaris
Dermatology |
Others
NO
The objective of this study is to examine the utility of BPO gelacne for vulgaris on trunk (back and chest).
Safety,Efficacy
Decrease in the number of inflammatory rashes / during 12 weeks of observation period
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
BPO gel will be applied for 12 weeks.
Topical antimicrobial agent(Nadifloxacin or Clindamycin) will be applied for 12 weeks.
16 | years-old | <= |
Not applicable |
Male and Female
1) Patients with acne vulgaris who have 10 or more inflammatory rashes on the trunk(Chest or bBack)
2) Patients who provided written informed consent after receiving an explanation of the details of the study
3) Patients aged 16 years old or older at the time informed consent was provided
For patients younger than 20 years old, representatives (parents, etc.) are required to provide informed consent.
1) Patients who had received treatment for acne vulgaris within one month of the start of the study
2) Patients in whom the study drug is contraindicated
3) Patients with continuous use of non-steroidal anti-inflammatory drugs (ibuprofen, etc.)
4) Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period
5) Patients who were considered inappropriate for the study by an investigator
6) Patients who had participated in other clinical studies and phase IV clinical trials of drugs for acne vulgaris within 6 months of the start of the study
40
1st name | |
Middle name | |
Last name | Makoto Kawashima |
Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
Department of Dermatology
8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan
03-3353-8111
m-kawash@derm.twmu.ac.jp
1st name | |
Middle name | |
Last name | Naomi Kanazawa |
EBC&M LLC.
Project planning & Development department
CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
03-6435-3833
naomi_kanazawa@ebc-m.com
Non-Profit Organization Health Institute Research of Skin
Maruho Co., Ltd
Profit organization
NO
2016 | Year | 04 | Month | 10 | Day |
Published
Completed
2016 | Year | 04 | Month | 08 | Day |
2016 | Year | 05 | Month | 01 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 04 | Month | 30 | Day |
2017 | Year | 05 | Month | 31 | Day |
2016 | Year | 04 | Month | 06 | Day |
2018 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025133
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