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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031979
Receipt No. R000036506
Scientific Title Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis : Superiority to rank-down therapy
Date of disclosure of the study information 2018/03/29
Last modified on 2019/07/05

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Basic information
Public title Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis
: Superiority to rank-down therapy
Acronym Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis
: Superiority to rank-down therapy
(Anticipate study)
Scientific Title Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis
: Superiority to rank-down therapy
Scientific Title:Acronym Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis
: Superiority to rank-down therapy
(Anticipate study)
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the group with proactive therapy (intermittent treatment) with BBP ointment and the group with rank-down therapy of steroids (dose-tapering) from BBP ointment to BV and to HB ointment for remission maintenance after serial treatment with BBP ointment in pediatric patients with moderate to severe atopic dermatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of relapse in patients during remission-maintenance treatment (relapse rate)
Key secondary outcomes (1)Duration of remission maintained (number of days) prior to relapse
(2)IGA score
(3)Modified SCORAD score
(4)Subjective symptom score (measured by NRS)
(5)Total serum IgE
(6)Peripheral blood eosinophilia, serum LDH, serum TARC

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 During remission-induction treatment, BBP ointment will be applied once daily every day for at least 1 week (up to 2 weeks) and moisturizer applied for skin care once daily. Moisturizers should be heparinoid or petrolatum, regardless of products.
Study treatment will be performed over the following Phase 1 and Phase II periods. Intermittent treatment will be performed on study area while maintaining remission. For the purpose of preventing relapse, even after resolution of rash, treatment will be given to the area rash was present at the time of initiation of remission-induction treatment.
Phase I (1 week): BBP ointment once daily every other day for 1 week after study enrollment. Moisturizer once daily throughout the period.
Phase II (3 weeks): BBP ointment twice per week for 3 weeks after completion of Phase I (1 week). Moisturizer once daily throughout the period.
Interventions/Control_2 During remission-induction treatment, BBP ointment will be applied once daily every day for at least 1 week (up to 2 weeks) and moisturizer applied for skin care once daily. Moisturizer should be heparinoid or petrolatum, regardless of products.
Study treatment will be performed over the following Phase 1 and Phase II periods. Dose-tapering will be performed on study area while maintaining remission. Treatment will be given to the area where rash is present.
Phase I (1 week): BV ointment once daily every day for 1 week after enrollment. Moisturizer once daily throughout the period.
Phase II (3 weeks): HB ointment once daily every day for 3 weeks after completion of Phase I (1 week). Moisturizer once daily throughout the period.
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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients must meet the following inclusion criteria to be eligible for this study.
(1) Japanese patients diagnosed with atopic dermatitis, prior to informed consent, according to the "Definition and diagnostic criteria for atopic dermatitis" by the Japanese Dermatological Association
(2) Elementary and middle schoolers aged >= 6 and <= 15 years at the time of informed consent and who can be treated on an outpatient basis
(3) An Investigator Global Assessment (IGA) score of 3 or more
(4) Patients who have used a strong or very strong topical steroid
(5) Informed consent by patient (where possible) or legal representative
Key exclusion criteria Patients meeting any of the following criteria are not to be enrolled in the study.
(1) Patients with skin infections caused by bacteria, fungi, spirochetes or viruses and patients with ectoparasitic skin diseases (scabies, pubic lice, etc.).
(2)History of hypersensitivity to any components of the topical steroid and/or moisturizer to be used
(3) Patients with ulcers (except for Bechet's disease) and patients with deep burns or frostbite of second degree or higher.
(4) Patients complicated with an active infection in the area the study drug is to be applied.
(5) Patients complicated with Kaposi's varicelliform eruption, scabies, molluscum contagious, psoriasis, disorders (Netherton syndrome, etc.) presenting with ichthyosiform erythroderma, collagen disease (SLE and dermatomyositis), and skin disorder on the area study drug is to be applied to, which can affect evaluation.
(6) Patients who used the following drug within 28 days prior to Visit 1 (at the time of informed consent)
> Systemic adrenocortical steroid (oral, injectable, suppository, and inhaled)
> Topical steroid (strongest)
> Systemic immunosuppressant
> Live vaccine
(7) Patients who received phototherapy (UVB, Narrow-band UVB, PUVA , etc.) within 28 days prior to Visit 1 (at the time of informed consent)
(8) Patients who participated in another clinical trial (including clinical trial of medical device) or clinical research involving intervention within 12 weeks prior to Visit 1 (at the time of informed consent)
(9) Patients determined by the investigator to be unsuitable for the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Mamitaro
Middle name
Last name Ohtsuki
Organization Jichi Medical University School of Medicine
Division name Department of Dermatology
Zip code 329-0498
Address 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL 0285-58-7360
Email mamitaro@jichi.ac.jp

Public contact
Name of contact person
1st name Kousaku
Middle name
Last name Kawada
Organization Satt Co., Ltd.
Division name Clinical research group Anticipate Clinical Research Support Secretariat
Zip code 160-0022
Address ACN Shinjuku Bld. 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-5312-5026
Homepage URL
Email anticipate@sa-tt.co.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Torii Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hattori clinic ethics review board
Address 1-15-18 Hachioji, Bessho, Tokyo
Tel 03-5919-2051
Email eight-clip@hattori-irb.com

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs031190047
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 佐藤皮フ科クリニック(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 29 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 Terminated
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 03 Month 29 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036506

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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