UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005158
Receipt number R000005803
Scientific Title Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation
Date of disclosure of the study information 2011/03/07
Last modified on 2011/05/02 09:10:18

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Basic information

Public title

Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation

Acronym

Randomized controlled trial of once- or twice-daily skincare for atopic dermatitis

Scientific Title

Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation

Scientific Title:Acronym

Randomized controlled trial of once- or twice-daily skincare for atopic dermatitis

Region

Japan


Condition

Condition

Atopic dermatitis

Classification by specialty

Clinical immunology Pediatrics Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the difference of clinical effectiveness between once and twice daily skincare for prevention of exacerbation in childhood atopic dermatitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The rates of patients with free of recurrence during 28 days of intervention.
2. No symptom days after entry of this intervention.

Key secondary outcomes

1. QOL of a caregiver (a parent)
2. Scoring atopic dermatitis (SCORAD)
3. Incidence of skin infection


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Once- daily skincare during 4 to 6 weeks

Interventions/Control_2

Twice-daily skincare During 4 to 6 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

1 years-old <=

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who are diagnosed as having atopic dermatitis based on the diagnostic criteria of Hanifin & Rajka
2) Patients who were diagnosed as having moderate or severe atopic dermatitis within a year
3) Patients whose skin condition should be maintained without skin eczema by using twice weekly betamethasone valerate ointment and twice daily emollient at the time of enrollment
4) Patients who can adhere twice-daily skincare treatment.

Key exclusion criteria

Patients who are taking oral steroids and/or oral immunosuppressive drug

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Ohya

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code


Address

2-10-1, Okura, Setagayaku, Tokyo

TEL

03-3416-0181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yukihiro Ohya

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code


Address

2-10-1, Okura, Setagayaku, Tokyo

TEL

03-3416-0181

Homepage URL


Email



Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

National Center for Child Health and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

2011 Year 03 Month 07 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

Open public recruiting

Date of protocol fixation

2010 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 01 Day

Last modified on

2011 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005803


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name