UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the utility of BPO products for acne vulgaris on trunk (back and chest)
Title of the study (Brief title)	Study of the utility of BPO products for acne vulgaris on trunk
Region	Japan

Condition
Condition	Acne vulgaris
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to examine the utility of BPO gelacne for vulgaris on trunk (back and chest).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decrease in the number of inflammatory rashes / during 12 weeks of observation period
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	BPO gel will be applied for 12 weeks.
Interventions/Control_2	Topical antimicrobial agent(Nadifloxacin or Clindamycin) will be applied for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with acne vulgaris who have 10 or more inflammatory rashes on the trunk(Chest or bBack) 2) Patients who provided written informed consent after receiving an explanation of the details of the study 3) Patients aged 16 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.
Key exclusion criteria	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 and phase IV clinical trials of drugs for acne vulgaris within 6 months of the start of the study
Target sample size	40

Research contact person
Name of lead principal investigator	Makoto Kawashima
Organization	Tokyo Woman's Medical University (Non-Profit Organization Health Institute Research of Skin)
Division name	Department of Dermatology
Address	8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	m-kawash@derm.twmu.ac.jp

Public contact
Name of contact person	Naomi Kanazawa
Organization	EBC&M LLC.
Division name	Project planning & Development department
Address	CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
TEL	03-6435-3833
Homepage URL
Email	naomi_kanazawa@ebc-m.com

Sponsor
Institute	Non-Profit Organization 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)

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	2016 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 08 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2018 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025133