UMIN-CTR Clinical Trial

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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