UMIN-CTR Clinical Trial

Basic information
Public title	The study of effect of gentian violet in chronic prurigo.
Acronym	The study of effect of gentian violet in chronic prurigo.
Scientific Title	The study of effect of gentian violet in chronic prurigo.
Scientific Title:Acronym	The study of effect of gentian violet in chronic prurigo.
Region	Japan

Condition
Condition	chronic prurigo
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study of effect of gentian violet in chronic prurigo
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	assessment of skin eruption based on photography VAS scale Behavioral rating scale
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	application of gentian violet
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients of chronic prurigo who are relative good general condition, able to apply gentian violet by themselves, able to assess the degree of pruritus, and with imformed consent.
Key exclusion criteria	The patients without severe liver dysfunction, undergoing artificial dialysis, allergy for gentian violet, nor being breast-feeding.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Sestuya Middle name Last name Aiba
Organization	Tohoku University School of medicine
Division name	Department of dermatology
Zip code	980-8574
Address	Seiryo-chou 1-1, aoba-ku, Sendai, Miyagi, Japan
TEL	022(717)-7271
Email	saiba@med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Hiromi Middle name Last name Suzuki
Organization	Tohoku University School of medicine
Division name	Department of Dermatology
Zip code	980-8574
Address	Seiryo-chou 1-1, aoba-ku, Sendai, Miyagi, Japan
TEL	022(717)-7271
Homepage URL
Email	hrmsuzuki@yahoo.co.jp

Sponsor
Institute	Department of Dermatology
Institute
Department

Funding Source
Organization	donation from companies.
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	Tohoku Univ. Hospital Clinical research Ethics Committee
Address	Seiryo-chou 1-1, aoba-ku, Sendai, Miyagi, Japan
Tel	022(717)7000
Email	protocol-support@trc.med.tohoku.ac.jp

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	2012 Year 09 Month 10 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	Preinitiation
Date of protocol fixation	2012 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 10 Day
Last follow-up date	2013 Year 08 Month 31 Day
Date of closure to data entry	2013 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 09 Month 06 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010388