Atopic Dermatitis Clinical Trial
Official title:
Investigation of Flare and Remission in Atopic Dermatitis in an Integrated Longitudinal Trial: Effects of Systemic Treatment With Cyclosporine A
The trial is an exploratory, single-centre, uncontrolled, open-label, interventional trial of up to 19 weeks' duration to investigate flare and remission in subjects with moderate-to-severe atopic dermatitis (AD) treated with cyclosporine A (CsA).
40 subjects with moderate-to-severe AD will be treated with a 3-week course of high-dose CsA,
which is a standard-of-care treatment regimen. After 3 weeks, all responders shift to oral
low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day
113).
In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5
mg/kg/day) for 3 weeks.
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