UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a new therapy for pincer and ingrown nails using thioglycollate salt and elastic wires
Title of the study (Brief title)	Development of a new therapy for pincer and ingrown nails
Region	Japan

Condition
Condition	pincer and ingrown nails
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of a new therapy for pincer and ingrown nails
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of the new therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	application of thioglycollate salt and elastic wires
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with pincer or ingrown nails
Key exclusion criteria	those who are considered ineligible for the entry
Target sample size	100

Research contact person
Name of lead principal investigator	Masayuki Amagai
Organization	Keio University Hospital
Division name	Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	amagai@a7.keio.jp

Public contact
Name of contact person	Masataka Saito
Organization	Keio University Hospital
Division name	Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	masataka@a7.keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

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)

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	2013 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 03 Day
Anticipated trial start date	2013 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 28 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014861