An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis
- Conditions
- Patients with atopic dermatitis in the remission maintenance phase
- Registration Number
- JPRN-UMIN000051817
- Lead Sponsor
- Asai Dermatology Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 160
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of days from the start day of remission maintenance therapy to relapse of atopic dermatitis
- Secondary Outcome Measures
Name Time Method umber 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