UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048837
Receipt number R000055649
Scientific Title Clinical evaluations of moisture skin care product in cancer patients.
Date of disclosure of the study information 2022/09/02
Last modified on 2022/09/02 18:25:47

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name