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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026338
Receipt No. 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

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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
Email 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
Email dermaycu@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030253

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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