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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019639
Receipt No. R000022286
Scientific Title Study of the utility of acute-phase and remission maintenance therapy with 2.5% benzoyl peroxide gel for moderate or severe acne vulgaris
Date of disclosure of the study information 2015/12/01
Last modified on 2018/08/22

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Basic information
Public title Study of the utility of acute-phase and remission maintenance therapy with 2.5% benzoyl peroxide gel for moderate or severe acne vulgaris
Acronym Study of the utility of BPO products for acne vulgaris
Scientific Title Study of the utility of acute-phase and remission maintenance therapy with 2.5% benzoyl peroxide gel for moderate or severe acne vulgaris
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Kawashima
Organization Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
Division name Department of Dermatology
Zip code
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
1st name
Middle name
Last name Naomi Kanazawa
Organization EBC&M LLC.
Division name Project planning & Development department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2015 Year 10 Month 19 Day
Date of IRB
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

Other
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

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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