Methotrexate vs Azathioprine in Atopic Dermatitis: A 5 year follow up study.
Recruiting
- Conditions
- atopic dermatits
- Registration Number
- NL-OMON24759
- Lead Sponsor
- Academic Medical Center, department of Dermatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
Inclusion Criteria
1. Subject is 18 years of age or older at baseline; both genders;
2. Subject has a diagnosis of AD for at least 6 months based on millennium criteria (with or without IgE) and UK-criteria;
Exclusion Criteria
1. Subject is pregnant, nursing, or planning pregnancy (men and women) while enrolled in the study and until 3 months after discontinuation of the study;
2. Subject has used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The primary efficacy variables are difference in mean change of the SCORAD and IGA between groups at different time points;<br /><br>2. Also the comparison in the proportion of subjects with a SCORAD reduction of 50% or more and the proportion of subjects with a IGA score of < 3 (clear / almost clear / mild) at different time points between MTX and AZA (Arm 1 and Arm 2).<br>
- Secondary Outcome Measures
Name Time Method 1. Frequency and severity of Adverse Events;<br /><br>2. Frequency of relapses. <br>