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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005536
Receipt No. R000006566
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
Date of disclosure of the study information 2011/05/02
Last modified on 2016/08/09

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Basic information
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
Condition atopic dermatitis
Classification by specialty
Clinical immunology Pediatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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]

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
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

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 浜松医科大学附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2011 Year 05 Month 01 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006566

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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