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

Not Applicable

• Conditions: atopic dermatitis

• Registration Number: JPRN-jRCTs031190047
• Lead Sponsor: Ohtsuki Mamitaro

Brief Summary

In pediatric patients with atopic dermatitis, we randomly assigned patients to proactive therapy group and rank-down therapy group after up to 2-week induction treatment and treat them with 4-week remission maintenance period. As a result, no statistically significant difference was found between the treatment groups regarding the relapse rate during the remission maintenance treatment period, which is the primary endpoint, and no significant difference was found between the treatment groups in the other ef

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-28
• Study Completion: 2021-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 52

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) 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified