Unique ID issued by UMIN | UMIN000031922 |
---|---|
Receipt number | R000036328 |
Scientific Title | A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients. |
Date of disclosure of the study information | 2018/03/27 |
Last modified on | 2019/03/29 14:30:53 |
A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients.
A study for the prevention of local irritation of the BPO preparation
A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients.
A study for the prevention of local irritation of the BPO preparation
Japan |
acne vulgaris
Dermatology |
Others
NO
Study for Japanese acne vulgaris patients, regarding the application method to demonstrate a clinical response to expect with prevention/reduction of the local irritation with the BPO preparation.
Safety
Phase IV
A local irritating evaluation (accompanying symptom) during testing period of 12 weeks: Erythema, desquamation, skin drying, itching, irritation / incandescence
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
4
Treatment
Medicine | Behavior,custom |
Gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience.
Application once a day consecutive for appropriate amount, 12 weeks
Non-gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience.
Application once a day consecutive for appropriate amount, 12 weeks
Gradual increase application group (BPO Gel) 40 subjects;BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects.
Application once a day consecutive for appropriate amount, 12 weeks
Non-gradual increase application group (BPO Gel) 40 subjects;BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects.
Application once a day consecutive for appropriate amount, 12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1) Moderate acne vulgaris (6-20 inflammatory rashes on one side of the face)
2) Written consent provided after receiving an explanation of the study content
3) Age >=20 years at the time of obtaining consent.
1) Treated for acne vulgaris within one month before the study
2) Contraindicated for the investigational drugs
3) Continuous use of nonsteroidal anti-inflammatory drugs (such as ibuprofen)
4) Pregnant or possibly pregnant women, lactating women, and women who wanted to become pregnant during the study period.
5) Judged as ineligible by the physician directing the study
6) Participation in another clinical study or post-marketing surveillance of other drugs for acne vulgaris within six months before the study.
120
1st name | Makoto |
Middle name | |
Last name | Kawashima |
Non-Profit Organization Health Institute Research of Skin
vice chief director
101-0047
1-8-9 Kamikanda, Chiyoda-ku, Tokyo, Japan
03-3256-2575
kawashima.makoto@twmu.ac.jp
1st name | Yoshitaka |
Middle name | |
Last name | Ogaki |
EBC&M LLC.
Clinical Business Department
105-0011
ShibaMatsuo BUILDING 4F 2-9-1, Shibakoen, Minato-ku, Tokyo, Japan
03-6435-3833
yoshitaka_ogaki@ebc-m.com
NPO Health Institute Research of Skin
Maruho Co.,Ltd.
Profit organization
IRB of Shinkokai
Hakuaido Building 3F, 1-18-7, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
03-5354-7388
kawabata@hifuka.com
NO
2018 | Year | 03 | Month | 27 | Day |
Unpublished
121
Completed
2018 | Year | 03 | Month | 16 | Day |
2018 | Year | 03 | Month | 27 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 20 | Day |
2019 | Year | 03 | Month | 08 | Day |
2019 | Year | 03 | Month | 28 | Day |
2018 | Year | 03 | Month | 27 | Day |
2019 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036328