UMIN-CTR Clinical Trial

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
Last 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
1st 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