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Tacrolimus 0·1% ointment for seborrhoeic dermatitis: an open‐label pilot study
Author(s) -
Braza T.J.,
DiCarlo J.B.,
Soon S.L.,
McCall C.O.
Publication year - 2003
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1046/j.1365-2133.2003.05383.x
Subject(s) - atlanta , medicine , dermatology , seborrhoeic dermatitis , library science , family medicine , pathology , computer science , metropolitan area
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 < 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.