UMIN-CTR Clinical Trial

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