UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the efficacy of skin care for dry skin by the targeted cancer therapies
Title of the study (Brief title)	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	Hitoshi Mizutani
Organization	Mie University
Division name	Department of Dermatology, Graduate School of Medicine
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	Hitoshi Mizutani
Organization	Mie University
Division name	Department of Dermatology, Graduate School of Medicine
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
Institute	Department of Dermatology, Mie University Graduate School of Medicine
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019567