UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006360 |
|---|---|
| Receipt number | R000007550 |
| Scientific Title | Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors. |
| Date of disclosure of the study information | 2011/09/20 |
| Last modified on | 2013/03/22 17:06:22 |
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Basic information
Public title
Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors.
Acronym
Moisturizer and basic dermatological data in skin adverse event of EGFR inhibitors.
Scientific Title
Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors.
Scientific Title:Acronym
Moisturizer and basic dermatological data in skin adverse event of EGFR inhibitors.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase 2 study to reveal the mechanism of skin adverse events of EGFR inhibitors and to assess the efficacy and safety of moisturizer for skin adverse events of EGFR inhibitors..
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Acquisition of basic dermatological data of the patients taking EGFR inhibitors.
Key secondary outcomes
The efficacy and safety of moisturizer for skin adverse events of EGFR inhibitors.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of "Hirudoid ointment" or "Hirudoid lotion"
Interventions/Control_2
No application
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.Lung cancer patient to be administrated gefitinib or elrotinib.
2.Person who obtained document and agreement by own free will on full understanding after enough explanation when participating about examination is received.
3.over 20 years old.
Key exclusion criteria
1.Person with skin disorder with wide body surface area.
2.Person with allergy to this moisturizer.
3.Person with severe bleeding tendency.
4.person who is judged as improper as included by the doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Moroi |
Organization
Kyushu University Hospital
Division name
Department of Dermatology
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka
TEL
092-642-5585
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Moroi |
Organization
Kyushu University Hospital
Division name
Department of Dermatology
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka
TEL
092-642-5585
Homepage URL
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
NPO Jasmin
Organization
Division
Category of Funding Organization
Other
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
九州大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 16 | Day |
Last modified on
| 2013 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007550
