UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006360
Receipt number R000007550
Scientific Title Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors.
Date of disclosure of the study information 2011/09/20
Last modified on 2013/03/22 17:06:22

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Basic information

Public title

Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors.

Acronym

Moisturizer and basic dermatological data in skin adverse event of EGFR inhibitors.

Scientific Title

Efficacy of moisturizer and acquisition of basic dermatological data in skin adverse event of epidermal growth factor receptor inhibitors.

Scientific Title:Acronym

Moisturizer and basic dermatological data in skin adverse event of EGFR inhibitors.

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Phase 2 study to reveal the mechanism of skin adverse events of EGFR inhibitors and to assess the efficacy and safety of moisturizer for skin adverse events of EGFR inhibitors..

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Acquisition of basic dermatological data of the patients taking EGFR inhibitors.

Key secondary outcomes

The efficacy and safety of moisturizer for skin adverse events of EGFR inhibitors.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Application of "Hirudoid ointment" or "Hirudoid lotion"

Interventions/Control_2

No application

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Lung cancer patient to be administrated gefitinib or elrotinib.
2.Person who obtained document and agreement by own free will on full understanding after enough explanation when participating about examination is received.
3.over 20 years old.

Key exclusion criteria

1.Person with skin disorder with wide body surface area.
2.Person with allergy to this moisturizer.
3.Person with severe bleeding tendency.
4.person who is judged as improper as included by the doctors.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Moroi

Organization

Kyushu University Hospital

Division name

Department of Dermatology

Zip code


Address

3-1-1 Maidashi, Higashiku, Fukuoka

TEL

092-642-5585

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoichi Moroi

Organization

Kyushu University Hospital

Division name

Department of Dermatology

Zip code


Address

3-1-1 Maidashi, Higashiku, Fukuoka

TEL

092-642-5585

Homepage URL


Email



Sponsor or person

Institute

Kyushu University Hospital

Institute

Department

Personal name



Funding Source

Organization

NPO Jasmin

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

九州大学病院


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 20 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


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

Terminated

Date of protocol fixation

2010 Year 11 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 05 Month 01 Day

Date analysis concluded

2013 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 16 Day

Last modified on

2013 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007550


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name