Seborrheic dermatitis is a chronic relapsing skin disorder that presents with erythema, scaling, and pruritus. It is estimated that between 3% and 5% of the population worldwide are affected by seborrheic dermatitis.1 Recent studies have shown the efficacy of pimecrolimus in treating facial seborrheic dermatitis.2- 5 The purpose of this study was to compare the safety and efficacy of topical pimecrolimus with hydrocortisone acetate in the treatment of patients with facial seborrheic dermatitis.
This randomized, investigator-blind, controlled clinical trial was approved by the ethics committee of the Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences (A.F., A.S., F.G., and Y.D.) and was carried out from January to July 2005 at the Razi Skin Hospital (M.D., K.B., and K.F.), Tehran, Iran, on 40 patients with a diagnosis of facial seborrheic dermatitis. Patients with malignant or active viral lesions on the face and those who had received antibiotics or immunosuppressive drugs or phototherapy during 1 month before and any topical therapy suspected to affect facial seborrheic dermatitis during 1 week before the beginning of the study were excluded. The patients were randomized according to a computer-generated randomization list to receive either pimecrolimus cream, 1% (Elidel; Novartis Pharmaceuticals, East Hanover, NJ), or hydrocortisone acetate cream, 1% (DermAid; Ego Pharmaceuticals, Braeside, Australia), twice daily for 2 weeks and then were followed up every 2 weeks for 4 weeks. The primary outcome measure was complete disappearance of the lesions. Also, clinical response to treatment was assessed on a 0- to 3-point scale for pruritus, scaling, and erythema (0 = none, 1 = mild, 2 = moderate, and 3 = severe).
Fisher exact and χ2 tests were used to compare the proportion of complete disappearance and adverse events, and the Mann-Whitney test was used to compare the clinical scale of study groups.
Eighteen patients in the pimecrolimus group and 19 patients in the hydrocortisone group completed the trial. There were not any significant differences in patients' baseline data, response to treatment, and relapse rate between treatment groups (Table; P>.05 for all measurements). Seven patients in the pimecrolimus group experienced burning sensation, whereas only 1 patient treated with hydrocortisone had this problem (P<.05).
Topical corticosteroids are the main treatment modality for facial seborrheic dermatitis. The chronic nature of disease and the numerous adverse effects of long-term use of corticosteroids make other treatment options such as pimecrolimus valuable. Two case reports2,3 and 1 open study4 have previously shown the efficacy of pimecrolimus therapy in seborrheic dermatitis. In the only randomized controlled trial published,5 the efficacy of pimecrolimus was similar to that of betamethasone valerate. Pimecrolimus cream had the same efficacy as hydrocortisone acetate cream in this study and may be a good therapeutic alternative for corticosteroids in treating facial seborrheic dermatitis with acceptable transient adverse events. Further studies should be performed to assess the efficacy and safety of long-term use of pimecrolimus and maintenance effects of this drug in this disease with a larger sample size.
Correspondence: Dr Firooz, Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, No. 79 Taleghani Ave, Tehran 14166, Iran (email@example.com).
Financial Disclosure: None reported.
Previous Presentation: The abstract of this manuscript was presented as a poster at the European Society for Dermatological Research Annual Meeting, September 22-24, 2005, Tubingen, Germany, and was published in the Journal of Investigative Dermatology, 2005;125(3)(suppl):A73.
Funding/Support: This study was financially supported by a research grant from the Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, and was performed at Razi Skin Hospital after approval by the ethics committee of the Center for Research and Training in Skin Diseases and Leprosy. Novartis Iran Company provided pimecrolimus creams, and Poober Company provided hydrocortisone acetate creams free of charge.
Trial Registration: isrctn.org Identifier: ISRCTN77370654.
Firooz A, Solhpour A, Gorouhi F, Daneshpazhooh M, Balighi K, Farsinejad K, Rashighi-Firoozabadi M, Dowlati Y. Pimecrolimus Cream, 1%, vs Hydrocortisone Acetate Cream, 1%, in the Treatment of Facial Seborrheic Dermatitis: A Randomized, Investigator-Blind, Clinical Trial. Arch Dermatol. 2006;142(8):1065-1086. doi:10.1001/archderm.142.8.1066