JPRN-UMIN000051817
Not yet recruiting
未知
An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis - 271-JMA-22003
Asai Dermatology Clinic0 sites160 target enrollmentOctober 1, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Patients with atopic dermatitis in the remission maintenance phase
- Sponsor
- Asai Dermatology Clinic
- Enrollment
- 160
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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