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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031922 |
Receipt No. | 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 |
Basic information | ||
Public title | A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients. | |
Acronym | A study for the prevention of local irritation of the BPO preparation | |
Scientific Title | A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients. | |
Scientific Title:Acronym | A study for the prevention of local irritation of the BPO preparation | |
Region |
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Condition | ||
Condition | acne vulgaris | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | A local irritating evaluation (accompanying symptom) during testing period of 12 weeks: Erythema, desquamation, skin drying, itching, irritation / incandescence |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment |
Intervention | |||
No. of arms | 4 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience. Application once a day consecutive for appropriate amount, 12 weeks |
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Interventions/Control_2 | Non-gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience. Application once a day consecutive for appropriate amount, 12 weeks |
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Interventions/Control_3 | 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 |
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Interventions/Control_4 | 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 |
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Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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. |
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Key exclusion criteria | 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. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Non-Profit Organization Health Institute Research of Skin
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Division name | vice chief director | ||||||
Zip code | 101-0047 | ||||||
Address | 1-8-9 Kamikanda, Chiyoda-ku, Tokyo, Japan | ||||||
TEL | 03-3256-2575 | ||||||
kawashima.makoto@twmu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | EBC&M LLC. | ||||||
Division name | Clinical Business Department | ||||||
Zip code | 105-0011 | ||||||
Address | ShibaMatsuo BUILDING 4F 2-9-1, Shibakoen, Minato-ku, Tokyo, Japan | ||||||
TEL | 03-6435-3833 | ||||||
Homepage URL | |||||||
yoshitaka_ogaki@ebc-m.com |
Sponsor | |
Institute | NPO Health Institute Research of Skin |
Institute | |
Department |
Funding Source | |
Organization | Maruho Co.,Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | IRB of Shinkokai |
Address | Hakuaido Building 3F, 1-18-7, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan |
Tel | 03-5354-7388 |
kawabata@hifuka.com |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 121 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036328 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |