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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025358
Receipt No. 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

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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
Email 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
Email nogita@hifuka.com

Sponsor
Institute Toshitatsu Nogita
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029191

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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