A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Not Applicable
Completed
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-UMIN000030265
- Lead Sponsor
- MIE HIFUKA CLINIC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with severe skin disorders on test site (both arms) and deemed inappropriate to participate in this study by the doctor. 2) Patients who have a history of hypersensitivity to heparin analog preparation. 3) Pregnant or lactating patients. Patients with suspicion of pregnancy. 4) Patients deemed inappropriate to participate in this study by the principal doctor or investigators. 5) Patients with hemorrhagic blood disease; e.g. Hemophilia, Thrombocytopenia, Purpura, etc. 6) Patients who are expected to promote serious consequences with minimal bleeding. 7) Patients who have undergone climacteric disorder or postmenopausal "hormone replacement therapy"
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of usefulness of long-term (12mo) application of ra148 on atopic disease by the principal doctor.
- Secondary Outcome Measures
Name Time Method 1) Severity classification (simple method) of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at the test site. 2) Evaluation of the digital images of the test site. 3) Questionnaires for QOL assessment in atopic dermatitis. 4) Evaluation of the patient's diaries (Medication compliance, Subjective symptoms, The degree of itchiness, etc.).