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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008099
Receipt No. R000009524
Scientific Title A double-blind, controlled trial to evaluate the efficacy and safety of vitamin K1 ointment for cetuximab and Panitumumab-induced acneiform eruption
Date of disclosure of the study information 2012/06/11
Last modified on 2015/07/17

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Basic information
Public title A double-blind, controlled trial to evaluate the efficacy and safety of vitamin K1 ointment for cetuximab and Panitumumab-induced acneiform eruption
Acronym Topical VitK1 for Cmab and Pmab-induced acneiform
Scientific Title A double-blind, controlled trial to evaluate the efficacy and safety of vitamin K1 ointment for cetuximab and Panitumumab-induced acneiform eruption
Scientific Title:Acronym Topical VitK1 for Cmab and Pmab-induced acneiform
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate efficacy and safety of Vitamin K1 ointment for cetuximab-induced acneiform eruption.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The number of acneiform eruptions of right and left lesions(face, neck, or chest) of the same patient before and after treatment
Key secondary outcomes Evaluate for acneiform eruption by using CTCAE v4.0 and MASCC scale, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.1% vitamin K1 ointment twice daily
Interventions/Control_2 Placebo ointment twice daily
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.Age: 20 or older
2.Cetuximab or Panitumumab-induced acneiform eruption on face, neck or chest
3.Written informed consent
Key exclusion criteria 1.Currently treated with vitamin K analog or antagonist
2.Pregnancy or brestfeeding
3.Not eligible judged by physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Hashimoto
Organization National Cancer Center Hoapital
Division name Pharmacy division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email hhashimo@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Hashimoto
Organization National Cancer Center Hoapital
Division name Pharmacy division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email hhashimo@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital Pharmacy division
Institute
Department

Funding Source
Organization National Cancer Center Hospital Pharmacy division
Organization
Division
Category of Funding 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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 11 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
2012 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2015 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 09 Month 01 Day
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 06 Month 04 Day
Last modified on
2015 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009524

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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