UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031922 |
|---|---|
| Receipt number | R000036328 |
| Scientific Title | A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients. |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2019/03/29 14:30:53 |
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Basic information
Public title
A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients.
Acronym
A study for the prevention of local irritation of the BPO preparation
Scientific Title
A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients.
Scientific Title:Acronym
A study for the prevention of local irritation of the BPO preparation
Region
| Japan |
Condition
Condition
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study for Japanese acne vulgaris patients, regarding the application method to demonstrate a clinical response to expect with prevention/reduction of the local irritation with the BPO preparation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
A local irritating evaluation (accompanying symptom) during testing period of 12 weeks: Erythema, desquamation, skin drying, itching, irritation / incandescence
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
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience.
Application once a day consecutive for appropriate amount, 12 weeks
Interventions/Control_2
Non-gradual increase application group (Epiduo Gel) 20 subjects;BPO preparation use experience.
Application once a day consecutive for appropriate amount, 12 weeks
Interventions/Control_3
Gradual increase application group (BPO Gel) 40 subjects;BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects.
Application once a day consecutive for appropriate amount, 12 weeks
Interventions/Control_4
Non-gradual increase application group (BPO Gel) 40 subjects;BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects.
Application once a day consecutive for appropriate amount, 12 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Moderate acne vulgaris (6-20 inflammatory rashes on one side of the face)
2) Written consent provided after receiving an explanation of the study content
3) Age >=20 years at the time of obtaining consent.
Key exclusion criteria
1) Treated for acne vulgaris within one month before the study
2) Contraindicated for the investigational drugs
3) Continuous use of nonsteroidal anti-inflammatory drugs (such as ibuprofen)
4) Pregnant or possibly pregnant women, lactating women, and women who wanted to become pregnant during the study period.
5) Judged as ineligible by the physician directing the study
6) Participation in another clinical study or post-marketing surveillance of other drugs for acne vulgaris within six months before the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kawashima |
Organization
Non-Profit Organization Health Institute Research of Skin
Division name
vice chief director
Zip code
101-0047
Address
1-8-9 Kamikanda, Chiyoda-ku, Tokyo, Japan
TEL
03-3256-2575
kawashima.makoto@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Ogaki |
Organization
EBC&M LLC.
Division name
Clinical Business Department
Zip code
105-0011
Address
ShibaMatsuo BUILDING 4F 2-9-1, Shibakoen, Minato-ku, Tokyo, Japan
TEL
03-6435-3833
Homepage URL
yoshitaka_ogaki@ebc-m.com
Sponsor or person
Institute
NPO 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
IRB of Shinkokai
Address
Hakuaido Building 3F, 1-18-7, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
Tel
03-5354-7388
kawabata@hifuka.com
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
| 2018 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
121
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
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036328
