FK 506 ointment 0.1% - A new therapeutic option for atopic blepharitis. Clinical trial with 14 patients

Background: Severe atopic blepharitis is difficult to treat, as topical ste roids offer only a limited therapeutic benefit with increasing side effects by time. Topical FK 506 was found to be efficient and safe for treatment o f atopic dermatitis in dermatologic studies. The use of topical FK 506 in a topic blepharitis has not been reported so far. Patients and methods: Fourteen patients with severe atopic blepharitis were treated with topical FK 506 0.1 %. The ointment was applied twice daily on the eye lids. Ophthalmologic examinations were scheduled at two weeks, two months and five months after onset of treatment. A score was defined for t he skin of the lid (edema, erythema, lichenification, oozing, excoriation a nd crusting) and for the eye lid margin (erythema, thickening, crusting) re spectively. Every patient graded pruritus on a visual analogue scale. Results: The mean skin score prior to treatment was 25.6 +/- 5.8, after two weeks 7.9 +/- 4.8 (p < 0.001), after two months 5.8 +/- 5.0 (p < 0.001) an d after five months 5.3 +/- 5.3 (p < 0.001). The mean score for the eye lid margin prior to treatment was 12.3 +/- 4.0, after two weeks 4.6 +/- 2.7 (p < 0.001), after two months 3.8 +/- 2.4 (p < 0.001) and after five months 4 .3 +/- 2.6 (p < 0.001). The mean score for pruritus prior to treatment was 8.1 +/- 1.3, after two weeks 2.0 +/- 1.4 (p < 0.001), after two months 1.3 +/- 0.8 (p < 0.001) and after five months 0.8 +/- 0.7 (p < 0.001). All pati ents assessed the overall situation under therapy as markedly improved. Conclusions: Topical FK 506 0.1 % ointment turns out to be an excellent the rapeutic option for treatment of severe atopic blepharitis. Long-term effic acy and safety have to be evaluated in long-term follow-up studies.