UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019639
Receipt number 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 16:58:25

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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 or person

Institute

Non-Profit Organization Health Institute Research of Skin

Institute

Department

Personal name



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

Value
https://center6.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