UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the utility of acute-phase and remission maintenance therapy with 2.5% benzoyl peroxide gel for moderate or severe acne vulgaris
Title of the study (Brief title)	Study of the utility of BPO products for acne vulgaris
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 effects of concomitant use of a BPO gel, adapalene gel, and external antimicrobial medicine for acute-phase acne vulgaris (inflammatory rash), and to evaluate the utility of BPO gel in the maintenance period in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PhaseI: Decrease in the number of inflammatory rashes / during 12 weeks of observation period PhaseII:Symptom maintenance period / period until development or increase of inflammatory rash) / during 12 weeks of observation period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Phase I Group A: BPO gel + Clindamycin product (Concomitant therapy group)
Interventions/Control_2	Phase I Group B: BPO gel +Adapalene gel (Concomitant therapy group)
Interventions/Control_3	Phase I Group C: Adapalene gel +Clindamycin product (Concomitant therapy group)
Interventions/Control_4	Phase II Group 2-A: Adapalene gel Monotherapy group
Interventions/Control_5	Phase II Group 2-B: BPO gel Monotherapy group
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	Phase I 1) Patients with moderate or severe acne vulgaris (6 to 30 inflammatory rashes on the right or left half of the face) 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. Phase II 1) Patients in whom inflammatory rashes were reduced to 5 or less on the face and 3 or less on the right or left half of the face within 12 weeks from commencement of phase I (acute phase) treatment 2) Patients who provided written informed consent after receiving another explanation of the details of the study in the maintenance period
Key exclusion criteria	Phase I 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 Phase II 1) Patients who were cons
Target sample size	180

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	2015 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 12 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	2015 Year 11 Month 05 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022286