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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024083
Receipt No. R000027723
Scientific Title Safety evaluation study at the using time of household hotpack use
Date of disclosure of the study information 2016/09/16
Last modified on 2017/06/01

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Basic information
Public title Safety evaluation study at the using time of household hotpack use
Acronym Safety evaluation study of household hotpack use
Scientific Title Safety evaluation study at the using time of household hotpack use
Scientific Title:Acronym Safety evaluation study of household hotpack use
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of household hotpac use with healthy adult
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of low-temperature burn
Key secondary outcomes Abnormality in the skin (discoloration, pain, itching, redness) Abnormality of physical condition

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Put a sample over clothes (underwear, shorts etc) in the lower abdomen more than 8 hours
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
39 years-old >=
Gender Female
Key inclusion criteria (1)Japanese
(2)Female
(3)Age:20~39
(At obtaining informed consent)
(4)Subjects giving written informed consent
Key exclusion criteria (1)Subjects who are judged as unsuitable for the study by the lead principal investigator.
(2)Subjects who use topical cream to under abdomen.
(3)Subjects who get hives and eczema by touching to warm things for a long time.
(4)Subjects who have skin allergy and cutaneous hypersensitivity.
(5)Subjects who are diabetes, disease of hematogenous disorder, hyperhidrosis, other disease of abdomen.
(6)Subjects who have skin symptoms in under abdomen that affect the study. For example, scratch, pimple, verrcura, burn.
(7)Subjects who have a navel piercing and tattoo in under abdomen.
(8)Subjects who go to dermatology.
(9)Subjects who are pregnant, could be pregnant in near future, or is breast feeding.
(10)Subjects who participate in other clinical study.
(11)Subjects who cause skin allergy symptoms (rash, redness, itching etc) by medicine, cosmetics, fomentations, plasters.
(12)Subjects who have a very good or bud warming.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name hospital director
Zip code
Address 6F Daiwa Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1599
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Maruya
Organization SOUKEN Co., Ltd
Division name Clinical trial management department
Zip code
Address 3F Daiwa Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email r_maruya@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd
Institute
Department

Funding Source
Organization Lotte Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 16 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
2016 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
2017 Year 05 Month 17 Day
Date trial data considered complete
2017 Year 05 Month 24 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 16 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027723

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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