UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024083 |
|---|---|
| Receipt number | 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 14:22:06 |
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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
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
r_maruya@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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