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Title: Ciclopiroxolamine At Least As Effective As Ketoconazole For Facial Seborrheic Dermatitis

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Dermatology 2003;206:3:233-240. "Randomized, Open-Labeled, Non-Inferiority Study between Ciclopiroxolamine 1% Cream and Ketoconazole 2% Foaming Gel in Mild to Moderate Facial Seborrheic Dermatitis"
04/15/2003 09:34:08 AM
By James Adams

Ciclopiroxolamine 1% cream is at least as effective as ketoconazole 2% foaming gel for the treatment of mild to moderate facial seborrheic dermatitis. Investigators from the Hôpital Pitié-Salpétrière in Paris and the Pierre-Fabre Research Institute in Vigoulet, France, conducted a randomised, open-label comparison of the two medications using a non-inferiority trial design. A population of 303 patients were included in the intent-to-treat analysis, and the per-protocol population consisted of 282 patients. The patients received either ciclopiroxolamine or ketoconazole. Ciclopiroxolamine 1% cream was applied twice a day for 28 days followed by a 28-day maintenance phase of one application per day. Ketoconazole 2% foaming gel was applied twice a week during the initial 28 days and once a week during the maintenance phase. Lesions were comparable in the two groups before treatment. After the initial phase of treatment, the intent-to treat-population showed 37% ciclopiroxolamine responders and 34% ketoconazole responders. At the same time, the per-protocol population showed responses of 39 and 36% for ciclopiroxolamine and ketoconazole, respectively. After the maintenance phase, response to ciclopiroxolamine was greater than response to ketoconazole in both study groups. Treatment response to ciclopiroxolamine compared with ketoconazole was 57 versus 44% in both the intent-to-treat and per-protocol populations. Ciclopiroxolamine had better local tolerance and global acceptability compared with ketoconazole, according to an intergroup analysis.

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