Patients with atopic dermatitis in the remission maintenance phase
Conditions
Interventions
None listed
Sponsors
Asai Dermatology Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have given written informed consent to participation in this research, 2.Patients aged 16 to 70 years on the day of informed consent with sufficient ability to make decisions regarding being investigated in the research,3.Patients with atopic dermatitis who underwent remission induction therapy using tacrolimus ointment, delgocitinib ointment, and topical corticosteroids classified as `very strong` or less in the Japanese guidelines for atopic dermatitis within 26 weeks before the start of treatment in the remission maintenance phase from mild to moderate conditions based on `Guide for Severity of Atopic Dermatitis` developed by the Health and Labour Sciences Research Group. 4.Patients with atopic dermatitis with IGA score <= 1 at the start of the treatment in the remission maintenance phase and at least 2 consecutive assessments within 14 to 60 days immediately before the start of the treatment,5.Patients who have started the following treatment within 30 days before informed consent. However, any treatment must be performed independently from participation in this research, and informed consent may be obtained on the day after the start of the treatment or later. Patients who experienced relapse of atopic dermatitis during the period from the start of remission maintenance therapy to informed consent, those who received additional treatment for relapse, and those receiving additional treatment for relapse during the research period are included as the subjects of this research. The content of scalp treatment does not matter.Difamilast group:Patients who have been treated with difamilast in accordance with the Japanese package insert.Use of emollients for areas without skin eruption other than the areas where difamilast is applied is allowed. For emollients, any type or dosage form can be used.Emollient group:Patients who have been receiving remission maintenance therapy using emollients as instructed by a physician.
Exclusion criteria
Exclusion criteria: 1.Patients with active or recurrent skin diseases other than atopic dermatitis that require treatment, 2.Patients with a history of treatment with difamilast at the research site (only in the difamilast group) before the start of the treatment in the remission maintenance phase,3.Patients who received systemic steroids, topical steroids (excluding the scalp) classified as `strongest` in the Japanese guidelines for atopic dermatitis, immunosuppressants, biological products, etc. within 26 weeks before the start of the treatment in the remission maintenance phase, 4.Patients who received phototherapy (UVB, narrow band UVB, PUVA, etc.) within 4 weeks before the start of the treatment in the remission maintenance phase, 5.Women who are pregnant or may possibly be pregnant and lactating women. Patients who wish to become pregnant during the research period, 6.Patients who have participated in a clinical trial or interventional clinical research within 4 weeks before the start of the treatment in the remission maintenance phase, 7.Patients with skin eruption with severe inflammation in >= 10% of body surface area within 4 weeks before the start of the treatment in the remission maintenance phase, 8.Patients whose treatment for atopic dermatitis was changed (discontinuation of the administration of the investigational drug, initiation of proactive therapy with TCSs or TCIs) during the period from the start of the treatment in the remission maintenance phase to the day of informed consent, 9.Other patients judged by the principal investigator to be ineligible for the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days from the start day of remission maintenance therapy to relapse of atopic dermatitis | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days from the start day of remission maintenance therapy to relapse of atopic dermatitis by site, Number of days of topical corticosteroids use from the start day of remission maintenance therapy to the end-of-trial visit | — |
Countries
Japan
Contacts
Public ContactChiho Shibata
DOT WORLD Co., Ltd. Clinical Operations Dept.
Outcome results
None listed