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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034432
Receipt No. R000036423
Scientific Title Use test of moisturizer for patients with skin disorder receiving EGFR 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 Use test of moisturizer for patients with skin disorder receiving EGFR inhibitor.
Acronym Use test of moisturizer for patients with skin disorder receiving EGFR inhibitor.
Scientific Title Use test of moisturizer for patients with skin disorder receiving EGFR inhibitor.
Scientific Title:Acronym Use test of moisturizer for patients with skin disorder receiving EGFR inhibitor.
Region
Japan

Condition
Condition Skin disorder caused by EGFR inhibitors
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effectiveness of moisturizer, slight in skin irritancy, good in feeling in use, 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 the safety(5% or less rate of adverse effect)
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 Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Use the test moisturizer in combination with treatment.
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Lung cancer patients with positive EGFR gene variation

Patients receiving gefitinib(Iressa),erlotinib(Tarceva),afatinib(Giotrif),osimertinib(Tagrisso),Cetuximab(Erbitax),Panitumumab(Vectibix)

Patients aged of 18 over at the time of enrollment
The sex does not matter
Key exclusion criteria Person who experienced skin symptoms such as contact dermatitis due to the ingredients of this research item and similar ingredients

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 Daisuke
Middle name
Last name Tsuruta
Organization Osaka city University Hospital
Division name Dermatology
Zip code 5458586
Address 1-5-7 Asahi-machi, Abeno-ku,Osaka
TEL 06-6645-3826
Email tatechiharu@gmail.com

Public contact
Name of contact person
1st name Chiharu
Middle name
Last name Tateishi
Organization Osaka city University Hospital
Division name Dermatology
Zip code 5458586
Address 1-5-7 Asahi-machi, Abeno-ku,Osaka
TEL 06-6645-3826
Homepage URL
Email tatechiharu@gmail.com

Sponsor
Institute Osaka city University 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 Osaka City University Hospital Certified Review Board
Address 1-2-7-601 Asahi-machi, Abeno-ku,Osaka
Tel 06-6645-3456
Email ethics@med.osaka-cu.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 30
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
2018 Year 03 Month 31 Day
Date of IRB
2018 Year 07 Month 03 Day
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 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=R000036423

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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