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

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 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


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

Value
https://center6.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