UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039633 |
|---|---|
| Receipt number | R000045200 |
| Scientific Title | Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema |
| Date of disclosure of the study information | 2020/02/28 |
| Last modified on | 2020/02/28 16:41:08 |
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Basic information
Public title
Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Acronym
Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Scientific Title
Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Scientific Title:Acronym
Safety and usefulness of the use of solid soap in patients with atopic dermatitis, seborrheic dermatitis and asteatotic eczema
Region
| Japan |
Condition
Condition
atopic dermatitis, seborrheic dermatitis and asteatotic eczema with symptoms on the face
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the safety and usefulness of transparent solid soaps in patients with mild to moderate atopic dermatitis and seborrheic dermatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety and usefulness
Key secondary outcomes
Subject background
Usage log
Subject questionnaire
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects use test facial soap instead of regular soap for four weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with skin diseases described in Condition
2.Japanese over 20 years old when obtaining consent
3.On participation in this study, Patients who have been given sufficient explanations, have gotten their full understanding and written consent.
4.Outpatient
5.Patients who is deemed appropriate by the Research Responsibility (charge) doctor.
Key exclusion criteria
1.Patients with skin diseases described in without Condition
2.Patients have inappropriate eczema (emarkable Erythema or erosion, etc...)
3.Patients have an allergy in ingredient of test soap.
4.Pregnant or possibly pregnant woman
5.Patients who is deemed inappropriate by the Research Responsibility (charge) doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Funasaka |
Organization
Nippon Medical School
Division name
Dermatology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
funasaka@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saeki |
Organization
Nippon medical school hospital
Division name
Dermatology
Zip code
113-8602
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
h-saeki@nms.ac.jp
Sponsor or person
Institute
Nippon medical school hospital
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA HEALTHCARE CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takano Medical Clinic.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital IRB
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
clinicaltrial@nms.ac.jp
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
| 2020 | Year | 02 | Month | 28 | 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
40
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
| 2018 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045200
| 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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