Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults - 14/06/12
Abstract |
Background |
Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis.
Objectives |
We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial.
Methods |
Adult patients were enrolled in a 12-week study. Subjects were randomized to tacrolimus 0.1% ointment (n = 16) or hydrocortisone 1% ointment (n = 14) applied twice daily to symptomatic regions of the face. The primary efficacy measure was the severity of facial seborrhea at the end of treatment (day 84) as measured by the Seborrhea Area and Severity Index–Face. Secondary efficacy measures included physician and patient assessment of seborrhea, the frequency of medication application, and adverse events.
Results |
The severity of facial seborrhea was similarly improved in both treatment groups (P = .86). Tacrolimus 0.1% ointment was used on significantly fewer days than 1% hydrocortisone ointment (mean missed doses per patient at first visit: 15.6 vs 7.6, P < .05; at last visit: 13.5 vs 7.7, P = .08). The majority of doses were missed because of lack of symptoms. The adverse event profile for both agents was similar; however, there was a numerically higher incidence of adverse events in the hydrocortisone group.
Limitations |
This was a small, open-label study.
Conclusion |
Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated.
Le texte complet de cet article est disponible en PDF.Key words : calcineurin inhibition, facial seborrheic dermatitis, frequency of application, hydrocortisone, topical tacrolimus ointment
Plan
Ms Clark, an independent medical writer, was involved in drafting this manuscript, with financial support provided by Astellas Pharma Canada Inc. This study was an investigator-initiated research project funded by Astellas Pharma Canada Inc. |
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Disclosure: Dr K. A. Papp has been a consultant and investigator for and has received grants and honoraria from Astellas Pharma Canada Inc. Ms Papp, Ms Dahmer, and Ms Clark have no conflicts of interest to declare. |
Vol 67 - N° 1
P. e11-e15 - juillet 2012 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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