UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000030253