UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016970
Receipt number R000019567
Scientific Title A study of the efficacy of skin care for dry skin by the targeted cancer therapies
Date of disclosure of the study information 2015/03/31
Last modified on 2017/05/03 09:47:49

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Basic information

Public title

A study of the efficacy of skin care for dry skin by the targeted cancer therapies

Acronym

A study of skin care for dry skin by the targeted therapies

Scientific Title

A study of the efficacy of skin care for dry skin by the targeted cancer therapies

Scientific Title:Acronym

A study of skin care for dry skin by the targeted therapies

Region

Japan


Condition

Condition

Colon and rectal cancer

Classification by specialty

Gastrointestinal surgery Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A comparative study of the dry skin condition of the moisturizer treated forearm for 6 weeks and non-treated side of the patients with targeted cancer therapies

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of the dry skin by skin care for 4 and 6 weeks
Clinical manifestation of dry skin by photo
Trans epidermal water loss
Skin capacitance

Key secondary outcomes

Changes in the stratum corneum component by skin care after 4 and 6 weeks therapy


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Evaluation of the skin condition of the right and left forearm after topical treatment with moisturizer of the face, neck, trunk and extremities except left forearm twice/day for 4 and 6 weeks

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

69 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with colon and rectal cancer treated with cetuximab

Key exclusion criteria

Patients with generalized skin diseases, patients treated with systemic corticosteroid and immunosuppressant and patients judged as inappropriate by the principal investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Mizutani

Organization

Mie University

Division name

Department of Dermatology, Graduate School of Medicine

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507 Japan

TEL

059-231-5025

Email

h-miuzta@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Mizutani

Organization

Mie University

Division name

Department of Dermatology, Graduate School of Medicine

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507 Japan

TEL

059-231-5025

Homepage URL


Email

h-miuzta@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Department of Dermatology, Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kao corporation

Name of secondary funder(s)

Kao corporation


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

三重大学医学部附属病院 Mie University Hospital


Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 31 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

2015 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 31 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 03 Month 30 Day

Last modified on

2017 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019567


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name