Unique ID issued by UMIN | UMIN000024874 |
---|---|
Receipt number | R000028538 |
Scientific Title | Study of the utility of combination therapy2.5% benzoyl peroxide gel and 2% ozenoxacin lotion for moderate or severe acne vulgaris |
Date of disclosure of the study information | 2017/02/15 |
Last modified on | 2018/09/27 09:45:28 |
Study of the utility of combination therapy2.5% benzoyl peroxide gel and 2% ozenoxacin lotion for moderate or severe acne vulgaris
Study of the utility of combination BPO andozenoxacin for acne vulgaris
Study of the utility of combination therapy2.5% benzoyl peroxide gel and 2% ozenoxacin lotion for moderate or severe acne vulgaris
Study of the utility of combination BPO andozenoxacin for acne vulgaris
Japan |
Acne vulgaris
Dermatology |
Others
NO
The objective of this study is to examine the effects of concomitant use of a BPO gel and Ozenoxacin lotion for acute inflammation-phase of acne vulgaris
Safety,Efficacy
Decrease in the number of inflammatory rashes / during 12 weeks of observation period
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
3
Treatment
Medicine |
GroupA:BPO gel Monotherapy group
GroupB:BPO gel +Ozenoxacin lotion (Concomitant therapy group)
GroupC:Ozenoxacin lotion +Adapalene gel (Concomitant therapy group)
13 | years-old | <= |
Not applicable |
Male and Female
1) Patients with moderate or severe acne vulgaris (6 to 30 inflammatory rashes on the right or left half of the face)
2) Patients who provided written informed consent after receiving an explanation of the details of the study
3) Patients aged 13 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 within 6 months of the start of the study
180
1st name | |
Middle name | |
Last name | Makoto Kawashima |
Tokyo Woman's Medical University
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 | Yoshitaka Ogaki |
EBC&M LLC.
Project planning & Development department
CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
03-6435-3833
yoshitaka_ogaki@ebc-m.com
Non-Profit Organization Health Institute Research of Skin
Maruho Co., Ltd
Profit organization
NO
2017 | Year | 02 | Month | 15 | Day |
Published
Completed
2016 | Year | 12 | Month | 20 | Day |
2017 | Year | 02 | Month | 01 | Day |
2016 | Year | 11 | Month | 17 | Day |
2018 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028538
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |