atopic dermatitis
Conditions
Interventions
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 hep
Sponsors
Jichi Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of relapse in patients during remission-maintenance treatment (relapse rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKousaku Kawada
Satt Co., Ltd. Clinical research group Anticipate Clinical Research Support Secretariat
Outcome results
None listed