UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031979 |
|---|---|
| Receipt number | 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 18:13:34 |
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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
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
anticipate@sa-tt.co.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036506
