[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 steroids offer only a limited therapeutic benefit with increasing side effects by time. Topical FK 506 was found to be efficient and safe for treatment of atopic dermatitis in dermatologic studies. The use of topical FK 506 in atopic blepharitis has not been reported so far.


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 the skin of the lid (edema, erythema, lichenification, oozing, excoriation and crusting) and for the eye lid margin (erythema, thickening, crusting) respectively. 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) and 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 patients assessed the overall situation under therapy as markedly improved.


CONCLUSIONS
Topical FK 506 0.1 % ointment turns out to be an excellent therapeutic option for treatment of severe atopic blepharitis. Long-term efficacy and safety have to be evaluated in long-term follow-up studies.
Mayer
K
K
Augenklinik, Heinrich-Heine-Universität, Düsseldorf.
Reinhard
T
T
Reis
A
A
Böhringer
D
D
Sundmacher
R
R
D000287:Administration, Topical; D000328:Adult; D001762:Blepharitis / Q000188:drug therapy* / Q000473:pathology; D018592:Cross-Over Studies; D003876:Dermatitis, Atopic / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus