Content » Vol 87, Issue 5

Clinical Report

Long-term Treatment with 0.1% Tacrolimus Ointment in Adults with Atopic Dermatitis: Results of a Two-year, Multicentre, Non-comparative Study

Sakari Reitamo, Jean-Paul Ortonne, Carsten Sand, Jan Bos, Frédéric Cambazard, Thomas Bieber, Christian Grønhøj Larsen, Malcolm Rustin, Regina Fölster-Holst, Marie Schuttelaar
DOI: 10.2340/00015555-0282


Atopic dermatitis often requires long-term treatment. This European, multicentre, non-comparative, 24-month, follow-up study investigated the efficacy and safety of 0.1% tacrolimus ointment applied to adults with atopic dermatitis. Patients (n = 672) applied a thin layer of 0.1% tacrolimus ointment twice daily for 3 weeks to all affected body areas. After 3 weeks, ointment was applied once daily. Clinical improvement became apparent after 2 weeks of treatment and 65.5% of patients had a rating of clearance, excellent or marked improvement by month 3. Skin burning (31.7%) was the most common causally-­related adverse event, followed by pruritus (11.3%) folliculitis (6.4%), alcohol intolerance (5.7%), herpes simplex (5.7%), skin infection (4.6%), skin erythema (3.3%) and hyperaesthesia (2.4%). The most commonly reported infections were flu syndrome (12.9%), skin infection (9.8%), folliculitis (7.4%) and herpes simplex (7.0%). Long-term treatment up to 24 months with 0.1% tacrolimus ointment is safe and efficacious in adults with atopic dermatitis.


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