UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020494 |
|---|---|
| Receipt number | R000023639 |
| Scientific Title | Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/03/18 14:16:28 |
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Basic information
Public title
Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris
Acronym
Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris
Scientific Title
Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris
Scientific Title:Acronym
Clinical trial on the usefulness and the safety of imidazole antifungal topical agent; ketoconazole cream for acne vulgaris
Region
| Japan |
Condition
Condition
acne vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of ketoconazol cream for acne vulgaris
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
inflammatory acne and comedo)by ketoconazole cream and nadifloxacin cream
Key secondary outcomes
Change of visual analogue scale score by the subjects three months after the start of this study
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
apply to half side of the face
-A group
R;ketoconazole cream, L;nadifloxacin cream
0.5g twice a day, topical, administration period: 12weeks
Interventions/Control_2
apply to half side of the face
-B group
L;ketoconazole cream, R;nadifloxacin cream
0.5g twice a day, topical, administration period: 12weeks
Interventions/Control_3
Interventions/Control_4
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
bisymmetrically acne vulgaris on face
Key exclusion criteria
-Patient who takes steroid or antifungus.
-Patient who has history of contact dermatitis due to external medicine which contains antifungus or antibiotic.
-If the attending physician has determined ineligible as a subject of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Yagami |
Organization
Fujita Health University
Division name
Department of dermatology
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192
TEL
0562-93-9256
ayagami@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Yagami |
Organization
Fujita Health University
Division name
Department of dermatology
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi Pref. 470-1192
TEL
0562-93-9256
Homepage URL
ayagami@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 03 | Month | 01 | 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
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 | 09 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023639
