Proactive management with topical corticosteroids ointment in pediatric atopic dermatitis :Superiority to rank-down therapy (Anticipate study)

JRCT ID: jRCTs031190047

Registered date:28/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 05/11/2019
• Target sample size: 90
• Study type: Interventional

Intervention(s)

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.

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.

Outcome(s)

• Primary Outcome: The incidence of relapse in patients during remission-maintenance treatment (relapse rate)

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 15age old
• Gender: Both

Include 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) Patients 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

Exclude 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.

Related Information

• Primary Sponsor: Ohtsuki Mamitaro
• Source(s) of Monetary Support: Torii Pharmaceutical Co., Ltd.