Tacrolimus 0·1% ointment for seborrhoeic dermatitis: an open-label pilot study

Summary 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