UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026338 |
|---|---|
| Receipt number | R000030253 |
| Scientific Title | The efficacy of the Lysophosphatidylcholine for atopic dermatitis with facial acne or folliculitis: A Multicenter, Randomized, Double-blind Trial |
| Date of disclosure of the study information | 2017/02/28 |
| Last modified on | 2019/09/02 16:37:14 |
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Basic information
Public title
The efficacy of the Lysophosphatidylcholine for atopic dermatitis with facial acne or folliculitis: A Multicenter, Randomized, Double-blind Trial
Acronym
The efficacy of the Lysophosphatidylcholine for atopic dermatitis with facial acne or folliculitis: A Multicenter, Randomized, Double-blind Trial
Scientific Title
The efficacy of the Lysophosphatidylcholine for atopic dermatitis with facial acne or folliculitis: A Multicenter, Randomized, Double-blind Trial
Scientific Title:Acronym
The efficacy of the Lysophosphatidylcholine for atopic dermatitis with facial acne or folliculitis: A Multicenter, Randomized, Double-blind Trial
Region
| Japan |
Condition
Condition
Atopic dermatitis
facial acne
folliculitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of moisturizing agent containing Lysophosphatidylcholine (LPC-1) in patients with atopic dermatitis accompanying facial acne or folliculitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Severity of atopic dermatitis (AD)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the test moisturizer containing Lysophosphatidylcholine (LPC-1)in combination with other treatment for 4 weeks.
Interventions/Control_2
Use the test moisturizer in combination with other treatment for 4 weeks.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)AD Patients with mild-to-severe disease severity based on the classification criteria by atopic dermatitis Japanese Dermatological Association.
(2)Patients who agree to stop using moisturizers other than test drugs on the face during the research period.
(3)Patients who have no problem for walking and answering to questionnaire survey.
(4)Patients who agree with the study and provide the written informed consent (consent from a legal guardian in case of under 20 years old) .
Key exclusion criteria
(1)Patients who are classified as the most severe atopic dermatitis.
(2)Patients who are under treatments of UV therapy or immunosuppressant drugs for atopic dermatitis.
(3)Patients who need to start new antihistamines.
(4)Patients taking antibiotics.
(5)In addition, patients who are inappropriate as subjects defined by doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukie Yamaguchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Environmental Immuno-Dermatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2675
dermaycu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Asami |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Environmental Immuno-Dermatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2675
Homepage URL
dermaycu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama city university medical center
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 | 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
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 | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030253
