UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluations of moisture skin care product in cancer patients.
Acronym	Clinical evaluations of moisture skin care product in cancer patients.
Scientific Title	Clinical evaluations of moisture skin care product in cancer patients.
Scientific Title:Acronym	Clinical evaluations of moisture skin care product in cancer patients.
Region	Japan

Condition
Condition	cancer patients
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate adherence, quality of life, efficacy and tolerability of skin care moisture product for cancer patient. skin care management (skin moisturizer,
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement of dry skin
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	skin moisture care product
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	cancer patient
Key exclusion criteria	patient with severe skin trouble
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Yamamoto
Organization	Wakayama Medical University
Division name	Dermatology
Zip code	641-0012
Address	811-1 Kimiidera, Wakayama, Japan
TEL	+81734410661
Email	yukiy@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Chikako Middle name Last name Kaminaka
Organization	Wakayama Medical University
Division name	Dermatology
Zip code	641-0012
Address	811-1 Kimiidera, Wakayama, Japan
TEL	+81734410661
Homepage URL
Email	kamikami@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	FAITH GROUP
Name of secondary funder(s)

IRB Contact (For public release)
Organization	wakayama medical University
Address	811-1 Kimiidera, Wakayama, Japan
Tel	+81734410661
Email	kamikami@wakayama-med.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3610
Org. issuing International ID_1	24701
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 02 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 01 Day
Last follow-up date	2024 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 02 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055649