UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008099 |
|---|---|
| Receipt number | 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 10:55:49 |
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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
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
hhashimo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital Pharmacy division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009524
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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