UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026657 |
|---|---|
| Receipt number | R000030612 |
| Scientific Title | Transdermal absorption of parabens added in a humectant and ointment and its effect on intestinal flora of the user |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/09/23 09:54:41 |
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Basic information
Public title
Transdermal absorption of parabens added in a humectant and ointment and its effect on intestinal flora of the user
Acronym
Transdermal absorption of parabens
Scientific Title
Transdermal absorption of parabens added in a humectant and ointment and its effect on intestinal flora of the user
Scientific Title:Acronym
Transdermal absorption of parabens
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of use of a humectant and ointment containing parabens on the change in the levels of parabens in urine and intestinal flora profile.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the levels of parabens in urine
Key secondary outcomes
Change in the intestinal flora profile
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Avoidance of using any personal care product containing parabens for 2 weeks.
2. Using a humectant or ointment containing parabens for 5 days.
3. Avoidance of using any personal care product containing parabens for 7 days.
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
| 5 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health care providers, researchers and their families who are using a humectant or ointment containing parabens.
Key exclusion criteria
Not applicable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuma Fukutomi |
Organization
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name
The Department of Diagnostic and Therapeutic Research
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa 252-0392 Japan
TEL
+81-42-742-8311
y-fukutomi@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuma Fukutomi |
Organization
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name
The Department of Diagnostic and Therapeutic Research
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa 252-0392 Japan
TEL
+81-42-742-8311
Homepage URL
y-fukutomi@sagamihara-hosp.gr.jp
Sponsor or person
Institute
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Environment Research and Technology Development Fund
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030612
| 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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| Registered date | File name |
