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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013266
Receipt No. R000012411
Scientific Title Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy
Date of disclosure of the study information 2014/02/25
Last modified on 2014/02/25

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Basic information
Public title Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy
Acronym Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy
Scientific Title Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy
Scientific Title:Acronym Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy
Region
Japan

Condition
Condition ulcerative colitis, familial adenomatous polyposis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy and comparison 1% of Dermacrin A ointment with 0.033% of Guaiazulene ointment after total colectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Grade of dermatitis at Week 2 and Week 4
Key secondary outcomes Relation between pH of the stool and Grade of dermatitis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1% of Dermacrin A ointment
Interventions/Control_2 0.033% of Guaiazulene ointment
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 1)patients with ulcerative colitis or familial adenomatous polyposis after total colectomy
2)patients from whom informed consent was obtained
Key exclusion criteria 1)history of hypersensitivity to treatment agent
2)patients judged to be unsuitable for this trial
3)patients under the age of 20 or with psychiatric disease

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimitsu Araki
Organization Mie University Graduate School of Medicine
Division name Gastrointestinal and Pediatric Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5294
Email taraki@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimitsu Araki
Organization Mie University Graduate School of Medicine
Division name Gastrointestinal and Pediatric Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5294
Homepage URL
Email taraki@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery
Institute
Department

Funding Source
Organization Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 25 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
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 06 Month 30 Day
Date trial data considered complete
2015 Year 07 Month 31 Day
Date analysis concluded
2015 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2014 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012411

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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