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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024256
Receipt No. R000027926
Scientific Title Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
Date of disclosure of the study information 2016/10/03
Last modified on 2018/11/07

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Basic information
Public title Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
Acronym Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
Scientific Title Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
Scientific Title:Acronym Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor
Region
Japan

Condition
Condition Lung cancer(adenocarcinoma)
Skin disorder(acneiform eruption)
Classification by specialty
Pneumology Hematology and clinical oncology Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Others
Basic objectives2 Others
Basic objectives -Others For EGFR gene-positive progress lungs adenocarcinoma, We examine mechanism and a skin physiologic change for the dermatopathy (acneiform eruption) to develop in Japanese in a treatment example frequently in the EGFR-TKI first time.
We examine the mechanism of the anti-inflammatory effect on dermatopathy of EGFR-TKI of the minocycline in addition.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Examination of the mechanism of the anti-inflammatory effect of the minocycline and the pathophysiology of the dermatopathy of EGFR-TKI in biopsy specimens
Key secondary outcomes Examination of biomarker of the dermatopathy by a skin physiologic change.
Quantification of cytokine and severity(CTCAE ver.4) of the anti-inflammatory effect of the minocycline.
Safety after the minocycline internal use.
Examination of an effect of EGFR-TKI and skin toxicity.

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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We plan participation registration of 20 cases to check the condition of a patient of the dermatopathy of EGFR-TKI which is end-point and the mechanism of the anti-inflammatory effect of the minocycline and do it with up to five years for the study period.
It is a test method, but the moisturizing agent starts use at the same time from the EGFR-TKI starting date.We measure a water content of the stratum, quantity of sebum and TEWL (transepidermal water loss), pH, skin apparatus measurement(1st) and perform tape stripping before start of therapy in skin biopsy(1st)( H.E. staining, immunohistochemical staining of inflammatory cytokine and quantification).
We add external preparation of the steroid by Grade1 (G1) appearance of the acneiform eruption(CTCAE.ver4.).
We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping when drug eruption turned worse in Grade2 (G2) and start minocycline internal use more.
We perform skin biopsy(3rd) and above-mentioned skin apparatus measurement(3rd) and tape stripping after minocycline internal use two weeks later.
When acneiform eruption does not reach G2, We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping as of four weeks later. Within a follow-up period, We do not perform biopsy, the skin apparatus measurement afterwards even if acneiform eruption becomes G2. We assume it only follow-up.
When acneiform eruption reaches G3, the skin biopsy and the above-mentioned skin apparatus measurement and tape stripping cancel the final examination after the third minocycline internal use two weeks later without performing them and introduce to dermatologist.
In addition, We are limited to a complier about the skin biopsy.
At the time of each medical examination, We evaluate the QOL using Skindex-16 which area skin disease standard, subjective symptoms, objective symptoms and these inspection items.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)The patient whom the diagnosis of the pulmonary adenocarcinoma established pathologically.
2) It is confirmed from an organization specimen by an insurance approved method to be EGFR gene variation-positive(exon19 deletion, exon21 L858R variation).
3) In an EGFR-TKI untreated recurrence, progress example, is, a dosage planned patient of gefitinib,erlotinib or afatinib.
4) ECOG performance status 0-1.
5)A main organ (marrow, heart, the lungs, the liver, kidney,etc) does not have a high obstacle.
Specifically, as for the marrow function, there are not obstacles more than grade3. As for the cardiac function, the liver function, the renal function, there are not obstacles more than grade2.As the breathing function does not have a interstitial pneumonia and there are not obstacles more than grade2.
6)20 years old or older, the sex does not matter.
7) After enough explanation of examination contents was carried out before final examination registration, a written agreement is provided from a patient.
Key exclusion criteria 1)The patient with history of the EGFR inhibitor treatment.
2)The patient who applied steroid ointment and retinoid or a drug having retinoid-like action to the skin part that was measurement subject within two weeks before clinical trial start.
3)The patient who takes steroid and the minocycline internal use.
4)Complications of a wide range of skin or the patient who has the past. (burn, psoriasis, scleroderma etc.)
5)The patient who received drug-caused skin eruption within two weeks before clinical trial start.
6)A patient with the past of sensitivity to heparin resemblance material component preparation.
7)A patient with hemorrhagic blood disorder(hemophilia, more than grade3 thrombocytopenia, purpura)
8)The patient that it is expected that a few bleeding causes a serious result.
9)A case having serious complications(liver damages more than grade2, renal damage etc.).
10)The patient who internal use is difficult, and has severe diarrhea (more than grade2).
11)The patient with overlap cancer of the activity.
12)A nursing girl and the patient who may be pregnant.
The patient who judges that a clinical study doctor (clinical study responsibility doctor,) is inadequate for reasons of others.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chigusa Shimono
Organization Wakayama medical university
Division name Third department of internal medicine,Oncology center
Zip code
Address Kimiidera 811-1,Wakayama city, Wakayama, in Japan
TEL 073-447-2300
Email cshimono@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Shimono
Organization Wakayama medical university
Division name Third department of internal medicine,Oncology center
Zip code
Address Kimiidera 811-1,Wakayama city, Wakayama, in Japan
TEL 073-447-2300
Homepage URL
Email cshimono@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Third department of internal medicine,Oncology center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 和歌山県立医科大学附属病院/Wakayama medical university hospital

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 03 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 Completed
Date of protocol fixation
2015 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2018 Year 11 Month 13 Day
Date of closure to data entry
2018 Year 11 Month 13 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 02 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027926

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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