UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034432
Receipt number 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 12:09:28

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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 or person

Institute

Osaka city University 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

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

Value
https://center6.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