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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034433
Receipt No. 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

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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
Email 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
Email aika0119@kuhp.kyoto-u.ac.jp

Sponsor
Institute Takatsuki red cross hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035342

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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