UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034433 |
|---|---|
| Receipt number | R000035342 |
| Scientific Title | Effective confirmation test of moisturizer for the dermatopathy of patients receiving EGFR(epidermal growth factor receptor)inhibitor |
| Date of disclosure of the study information | 2018/10/10 |
| Last modified on | 2019/03/31 10:59:11 |
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Basic information
Public title
Effective confirmation test of moisturizer for the dermatopathy of patients receiving EGFR(epidermal growth factor receptor)inhibitor
Acronym
Effective confirmation test of moisturizer for the dermatopathy of patients receiving EGFR inhibitor
Scientific Title
Effective confirmation test of moisturizer for the dermatopathy of patients receiving EGFR(epidermal growth factor receptor)inhibitor
Scientific Title:Acronym
Effective confirmation test of moisturizer for the dermatopathy of patients receiving EGFR inhibitor
Region
| Japan |
Condition
Condition
Patients receiving EGFR inhibitor
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effectiveness of moisturizer(cosmetics)which in superior to a conventional product(ethical drug)in usability for a dry symptom of skin emerging in the lung cancer treatment using the EGFR inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of skin dryness(skin findings)
Key secondary outcomes
Skin physiological verification(changes in skin measurement value and cytokine in epidermal horny layer)
Changes in stratum corneum water content,epidermal water transpiration amount,sebum quantity
Improvement of QOL and feeling of use of this research product by questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the test moisturizer in combination with treatment at more than twice a day
Interventions/Control_2
Continue a convientional product(ethical drug)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lung cancer patients with positive EGFR gene variation
Patients receiving gefitinib(Iressa),erlotinib(Tarceva)and afatinib(Giotrif)
Patients aged of 20 to 90 at the time of enrollment
The sex does not matter
After receiving sufficient explanation for participation in this research, after sufficient understanding,the patient himself or herself
Key exclusion criteria
Person who experienced skin symptoms such as contact dermatitis due to the ingredients of this research item and similar ingredients
Person who cannot evaluate it by the QOL method by himself or herself
Person who cannot use the moisturizer by himself or herself
In addiction,parson who the research staff judged inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aika |
| Middle name | |
| Last name | Okuno |
Organization
Takatsuki red cross hospital
Division name
Dermatology
Zip code
569-1045
Address
1-1-1, Abuno, Takatsuki-shi, Osaka
TEL
0726-96-0571
aika0119@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Aika |
| Middle name | |
| Last name | Okuno |
Organization
Takatsuki red cross hospital
Division name
Dermatology
Zip code
569-1045
Address
1-1-1, Abuno, Takatsuki-shi, Osaka
TEL
0726-96-0571
Homepage URL
aika0119@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Takatsuki red cross hospital
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co.,Ltd
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
Takatsuki red cross hospital Certified Review Board
Address
1-1-1 Abuno Takatsuki-city Osaka
Tel
072-696-0571
aika0119@kuhp.kyoto-u.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
| 2018 | Year | 10 | 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
13
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
| 2017 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035342
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| Registered date | File name |
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