Ann Dermatol.  2015 Oct;27(5):523-530. 10.5021/ad.2015.27.5.523.

Maintenance Therapy of Facial Seborrheic Dermatitis with 0.1% Tacrolimus Ointment

• Kim HO
• Yang YS
• Ko HC
• Kim GM
• Cho SH
• Seo YJ
• Son SW
• Lee JR
• Lee JS
• Chang SE
• Che JW
• Park CW

• KMID: 2171452
• DOI: http://doi.org/10.5021/ad.2015.27.5.523

Abstract

BACKGROUND
Topical calcineurin inhibitors (TCIs) have been successfully used to treat seborrheic dermatitis (SD) patients. Meanwhile, treatment of atopic dermatitis (AD) with low-dose, intermittent TCI has been proved to reduce disease flare-ups. This regimen is known as a maintenance treatment.
OBJECTIVE
The aim of this trial was to investigate the efficacy and tolerability of a maintenance treatment with tacrolimus ointment in patients with facial SD.
METHODS
During the initial stabilization period, patients with facial SD or AD applied 0.1% tacrolimus ointment twice daily for up to 4 weeks. Clinical measurements were evaluated on either in the whole face or on separate facial regions. When an investigator global assessment score 1 was achieved, the patient applied tacrolimus twice weekly for 20 weeks. We also compared our results with recent published data of placebo controlled study to allow an estimation of the placebo effect.
RESULTS
The time to the first relapse during phase II was similar in both groups otherwise significantly longer than the placebo group. The recurrence-free curves of two groups were not significantly different from each other; otherwise the curve of the placebo group was significantly different. There were no significant differences between the 2 groups in the number of DEs, and treatment days for disease exacerbations (DEs). The adverse event profile was also similar between the 2 groups. During the 20 weeks of treatment, the study population tolerated tacrolimus ointment well.
CONCLUSION
The results of this study suggest that maintenance treatment with tacrolimus may be effective in preventing the occurrence of facial SD exacerbations.

Keyword

Maintenance therapy; Seborrheic dermatitis; Tacrolimus ointment

MeSH Terms

Calcineurin
Dermatitis, Atopic
Dermatitis, Seborrheic*
Humans
Placebo Effect
Recurrence
Research Personnel
Tacrolimus*
Calcineurin
Tacrolimus

Figure

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  Fig. 1 Study design.

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  Fig. 2 Clinical measures evaluated in 7 divided facial parts (forehead, periorbital, nose, chin, cheeks, perioral and periauricular).

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  Fig. 3 Flow diagram. Total 195 patients are enrolled and 112 patients completed the clinical trial. Forty (32.5%) patients in the seborrheic dermatitis group and 26 (34.7%) patients in the atopic dermatitis group discontinued the study during the phase I.

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  Fig. 4 Time to first disease exacerbation (DE). SD: seborrheic dermatitis, AD: atopic dermatitis.

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  Fig. 5 Percentage of patients with investigator global assessment ≤1 in 7 divided facial parts during phase II (*p<0.05). SD: seborrheic dermatitis, AD: atopic dermatitis.

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