UMIN-CTR Clinical Trial

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