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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

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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
Japan

Condition
Condition acne vulgaris
Classification by specialty
Dermatology
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
Medicine Behavior,custom
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
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
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
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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
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.
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.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Kawashima
Organization Non-Profit Organization Health Institute Research of Skin
Division name vice chief director
Zip code 101-0047
Address 1-8-9 Kamikanda, Chiyoda-ku, Tokyo, Japan
TEL 03-3256-2575
Email kawashima.makoto@twmu.ac.jp

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name Ogaki
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
Email 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
Email 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
2018 Year 03 Month 27 Day

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
2018 Year 03 Month 16 Day
Date of IRB
2018 Year 03 Month 27 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 20 Day
Date trial data considered complete
2019 Year 03 Month 08 Day
Date analysis concluded
2019 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 29 Day


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


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