UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025358 |
|---|---|
| Receipt number | R000029191 |
| Scientific Title | Quantitative Determination of Nadifloxacin in Follicles of Acne Patients Treated by Topical Nadifloxacin With or Without Adapalene and Benzoyl Peroxide |
| Date of disclosure of the study information | 2016/12/21 |
| Last modified on | 2019/06/27 16:27:00 |
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Basic information
Public title
Quantitative Determination of Nadifloxacin in Follicles of Acne Patients Treated by Topical Nadifloxacin With or Without Adapalene and Benzoyl Peroxide
Acronym
Measurement of the Level of Nadifloxacin in Follicles of Acne
Scientific Title
Quantitative Determination of Nadifloxacin in Follicles of Acne Patients Treated by Topical Nadifloxacin With or Without Adapalene and Benzoyl Peroxide
Scientific Title:Acronym
Measurement of the Level of Nadifloxacin in Follicles of Acne
Region
| Japan |
Condition
Condition
Acne
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the Level of Nadifloxacin in Follicles of Among Acne Patients Treated by Topical Nadifloxacin With or Without Adapalene and Benzoyl Peroxide
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Level of Nadifloxacin in Follicles of Acne
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nadifloxacin
Interventions/Control_2
Adapalene
Interventions/Control_3
Benzoyl Peroxide
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
(1) The patient who is diagnosed as Acne disease
(2) Hospitalization or Outpatient: Outpatient
(3) Age: over 20 years old (at taking informed consent)
Key exclusion criteria
(1) The patient who had a following treatment within 4 weeks prior to the initiation of test drug treatment
Facial chemical peering, Leaser therapy, or Phototherapy
(2) The patient who had a following treatment within 2 weeks prior to the initiation of test drug treatment
Use of Nadifloxacin on his/her face, Facial aesthetic treatment, Use of facial cleanser with scrub
(3) The patient who would use or will not stop to use agent for skin (all of prescription medicine and OTC medicine) during the period of the study
(4) Pregnant woman, might be pregnant woman, and/or Breastfeeding woman
(5) The patient who is hypersensitivity to ingredients of test drug
(6) The patient to whom physician recognize him/her will not be included in the study because of his/her history and complication of systemic diseases
(7) The patient to who is participating other clinical research or study
(8) The patient to whom physician judge as inappropriate for this clinical study due to safely issues
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitatsu Nogita |
Organization
Shinjukuminamiguchihifuka
Division name
Director
Zip code
Address
Hakuaido Bldg. 3F, 1-18-7 Nishishinjuku, Shinjukuku, Tokyo, Japan
TEL
03-3343-4103
nogita@hifuka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitatsu Nogita |
Organization
Shinjukuminamiguchihifuka
Division name
Director
Zip code
Address
Hakuaido Bldg. 3F, 1-18-7 Nishishinjuku, Shinjukuku, Tokyo, Japan
TEL
03-3343-4103
Homepage URL
nogita@hifuka.com
Sponsor or person
Institute
Toshitatsu Nogita
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
医療法人社団 新光会 新宿南口皮膚科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 21 | 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
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2019 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029191
