Tacrolimus 0.1% ointment for seborrhoeic dermatitis: an open-label pilot study

BACKGROUND: As a topical immunosuppressant, tacrolimus ointment may be beneficial in the treatment of seborrhoeic dermatitis, while avoiding adverse effects related to long-term use of topical corticosteroids. OBJECTIVES: To determine the safety and efficacy of topical tacrolimus 0.1% ointment in the treatment of seborrhoeic dermatitis. METHODS: Sixteen subjects (15 men and one woman) were enrolled in a 6-week, open-label, uncontrolled trial of daily topical tacrolimus 0.1% ointment. Following a 2-week washout period for subjects using conventional therapy for seborrhoeic dermatitis, study medication was applied nightly to affected areas until clinical clearance occurred, and then for 7 days thereafter. Lesional extent and severity were assessed at baseline (day 0), at week 2 and at week 6 using the following parameters: (i). clinical assessment of erythema and scaling using a 0-3 scale; (ii). investigator global assessment; (iii). subject global assessment using a 0-6 scale; and (iv). serial photography. RESULTS: Thirteen of 16 (81%) subjects completed the study protocol; three subjects were lost to follow-up at week 6. Relative to the mean baseline value, the mean lesional erythema scores improved by 66.1% and 70.9% at weeks 2 and 6, respectively. Compared with baseline, the mean scaling scores improved by 63.7% at week 2 and 87.8% at week 6. These observations were statistically significant (P < 0.05, Wilcoxon two-sample test). Mean investigator global assessment scores improved by 76.6% at week 2 and 82.7% at week 6, relative to the mean baseline value. Mean subject global assessment scores also improved, by 69.4% at week 2 and 83.5% at week 6, relative to the mean baseline value. Other than transient application site pruritus/burning in two subjects, no serious adverse events were observed. CONCLUSIONS: This pilot study suggests that topical tacrolimus 0.1% ointment is efficacious in the short-term treatment of seborrhoeic dermatitis. Further controlled trials are warranted, to determine its efficacy and safety for this common condition.