UMIN-CTR Clinical Trial

Public title

A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis

Acronym

Efficacy and safety of proactive management in childhood atopic dermatitis

Scientific Title

A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis

Scientific Title:Acronym

Efficacy and safety of proactive management in childhood atopic dermatitis

Region

Japan

Condition

atopic dermatitis

Classification by specialty

Clinical immunology	Pediatrics	Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of proactive management in pediatric subjects with atopic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Proportion of patients with SCORAD < 20 and SCORAD <50 at each study visit [Time Frame: 24 months]

Key secondary outcomes

Decrease of total serum IgE after 3, 6, 12 and 24 months of treatment [Time Frame: at 3, 6, 12 and 24 months]
Change of immunological parameters (blood eosinophil count, TARC, specific IgE, IL-4, IL-5, IL-13, IL-17, IL-33, IFN-gamma) [Time Frame: at 3, 6, 12 and 24 months]
Quality of life (Children's dermatology life quality index and the dermatitis family impact questionnaire) at 6, 12 and 24 months.
Intensity of pruritus at each day as reported in the patient's diary by means of visual analogue scale (VAS)
Change of serum and salivary cortisol level at 6, 12 and 24 months [Time Frame: at 6, 12 and 24 months]
Local side effects on the skin, and incidence and severity of adverse event at each study visit [Time Frame: 24 months]

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

A proactive approach by using topical corticosteroids (i.e. twice-a-week) to all previously identified affected areas with confirmation of no exacerbation.
At exacerbation, patients apply topical corticosteroids everyday and subsequently return proactive application to any new skin areas where AD lesions have appeared.

Interventions/Control_2

A conventional treatment using topical corticosteroids when flare.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

15

years-old

>=

Gender

Male and Female

Key inclusion criteria

Eligible patients are boys and girls aged 3 months to 15 years with a diagnosis of atopic dermatitis according to the criteria of Hanifin and Rajka. The patients had moderate to severe AD as defined by the scoring system of Rajka and Langeland.

Key exclusion criteria

The exclusion criteria is as followed; (1) The patients receiving any additional systemic therapies included corticosteroids, nonsteroidal immunosuppressive agents or biological immunotherapy, (2) the patients who has a past history of cardiovascular disease, liver dysfunction, kidney disease and other current serious medical problems.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuki Fukuie

Organization

Hamamatsu University School of Medicine

Division name

Department of Pediatrics

Zip code

Address

Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN

TEL

053-435-2312

Email

fukuie-t@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Tatsuki Fukuie

Organization

Hamamatsu University School of Medicine

Division name

Department of Pediatrics

Zip code

Address

Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN

TEL

053-435-2312

Homepage URL

http://www.hama-med.ac.jp/

Email

fukuie-t@hama-med.ac.jp

Institute

Division of Allergy, Department of Medical Specialties, National Center for Child Health and Development

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Young Scientists B (No.23791165)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学附属病院（静岡県）

Date of disclosure of the study information

2011

Year

05

Month

02

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27075216

Number of participants that the trial has enrolled

Results

Abstract
Proactive therapy for atopic dermatitis (AD) effectively prevents exacerbation. However, its role in preventing subsequent sensitization to allergens has not been prospectively studied. We investigated whether proactive therapy for AD can effectively impact immunological parameters in a randomized, investigator-blinded, parallel group study. Thirty patients aged 3 months to 7 years with moderate to severe AD who had undergone an AD educational program were allocated to a proactive treatment group or a reactive treatment group. During the disease control period, patients in the proactive group performed intermittent preventive application of topical corticosteroid for 1 year. Changes in the severity scoring, quality of life measures and immunological parameters (serum thymus and activation regulated chemokine [TARC], total immunoglobulin E [IgE] and house dust mite-specific IgE levels) were evaluated and compared between the proactive and reactive treatment groups. Although the average topical corticosteroid ointment use per day in both groups was not significantly different, the severity and quality of life scores were significantly lower in the proactive group than in the reactive group at the final visit. In addition, compared with baseline levels, serum TARC levels remained significantly lower during proactive therapy, while house dust mite-specific IgE levels were significantly increased only in the reactive group. The results suggest that in addition to controlling the severity of AD, intermittent preventive administration of topical corticosteroids may prevent an increase in aeroallergen-specific IgE levels in patients with childhood AD. The use of TARC levels as a biomarker for AD remission is also supported.

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

01

Day

Last follow-up date

2013

Year

04

Month

01

Day

Date of closure to data entry

2013

Year

05

Month

01

Day

Date trial data considered complete

2013

Year

05

Month

01

Day

Date analysis concluded

2014

Year

05

Month

01

Day

Other related information

Registered date

2011

Year

05

Month

01

Day

Last modified on

2016

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006566