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
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
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
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
