Proactive Treatment of Adult Facial Seborrhoeic Dermatitis with 0.1% Tacrolimus Ointment: Randomized, Double-blind, Vehicle-controlled, Multi-centre Trial

Abstract

The effectiveness of intermittent topical tacrolimus to prevent relapse in patients with stabilized facial seborrhoeic dermatitis has not been evaluated. The aim of this study was to determine whether proactive use of 0.1% tacrolimus ointment can keep adult facial seborrhoeic dermatitis in remission. A total of 75 patients who had stabilized facial seborrhoeic dermatitis after 2 weeks' (open-label induction) treatment with 0.1% tacrolimus were randomized in a double-blind fashion to treatment with 0.1% tacrolimus once a week, twice a week, or vehicle twice a week, for 10 weeks (maintenance). Significant improvement in erythema, scaling and pruritus compared with baseline was maintained during the maintenance phase in both tacrolimus groups, but not in the vehicle group. The mean recurrence rate according to global assessment was significantly higher in the tacrolimus once-weekly group than in the twice-weekly group. In conclusion, twice-weekly treatment with 0.1% tacrolimus ointment had superior effects in keeping facial seborrhoeic dermatitis in remission.

Maintenance Therapy of Facial Seborrheic Dermatitis with 0.1% Tacrolimus Ointment

“…The median time to first DEs was not significantly different between the two groups (mean±standard deviation: 41.17±26.41 days vs. 40.55±24.84 days; p =0.38). In the previous study, the median time to first DE of the placebo group was 18.20±9.44 days 24 . It was shown that the median time to the first DE of both groups of our study were longer than that of the placebo group of the previous study, although the maintenance period was different (20 weeks vs. 10 weeks).…”

“…4 ). In the previous study 24 , all of the 10 patients of the placebo group had DE (IGA ≥2) in 10 weeks. Eight patients of the placebo group had DE at 2 weeks, one patient at 4 weeks, and the other one patient at 6 weeks.…”

“…Previous trials have indicated that maintenance therapy with tacrolimus is more successful in preventing AD flares than reactive vehicle treatment 13 18 25 . Previous studies with a similar protocol used maintenance therapy or proactive treatment 18 19 24 26 . To the best of our knowledge, this is the first study to evaluate the efficacy and tolerability of maintenance therapy with TCI for SD.…”

“…As this study was a comparative study of two different diseases, the IGA instead of both the eczema area and severity index and seborrhea area and severity index was chosen for the evaluation of the severity of facial AD and SD to ensure consistency. Also, for estimating the placebo effect, the results were compared with those of the placebo group of a recent study of proactive treatment with 0.1% tacrolimus ointment twice weekly in Korea 24 . Raw data were obtained from the authors of the paper 24 .…”

“…Also, for estimating the placebo effect, the results were compared with those of the placebo group of a recent study of proactive treatment with 0.1% tacrolimus ointment twice weekly in Korea 24 . Raw data were obtained from the authors of the paper 24 .…”