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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026657
Receipt No. 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

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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
Email 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
Email y-fukutomi@sagamihara-hosp.gr.jp

Sponsor
Institute Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030612

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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