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Friday 10 March 2006

Topical 2% ketoconazole warnings for long term usage.

By: Brian Beger, Charles Barranco

A 52-week open label study of the safety of ketoconazole USP 2% topical gel in the treatment of seborrheic dermatitis

Introduction: Seborrheic dermatitis is a common inflammatory scaling disease affecting areas of the skin with sebaceous glands.

Seborrheic dermatitis may appear in infancy but is not present again until the onset of puberty. The etiology of seborrheic dermatitis is not well understood but several factors are believed to contribute including the presence of Malassezia spp. (e.g., P.ovale). In well controlled clinical trials ketoconazole USP 2% topical gel showed efficacy in the treatment of seborrheic dermatitis when applied once daily for 14 days.

Objective: The objective of this ongoing study is to evaluate the safety of ketoconazole USP 2% topical gel when applied for up to 52 weeks.

Methods: This is an ongoing open-label, multi-center, non-controlled study. A total of approximately 530 subjects will be enrolled at approximately 27 US study centers. Subjects will apply ketoconazole USP 2% topical gel once daily for up to 52 weeks. Areas of seborrheic dermatitis to be treated and evaluated are: scalp hairline; postauricular areas; eyebrows and bridge of nose; naso-labial folds; sternum. At every visit the investigators will perform an Investigator’s Global Assessment (IGA) of the overall severity of seborrheic dermatitis based on the more severe of scaling or erythema on the treatment areas using a 5-point scale (0 = completely clear to 4 = severe). Subjects must have an IGA >=3 to enroll. Subjects will discontinue treatment if the seborrheic dermatitis clears (IGA <=1) and will re-initiate treatment if the seborrheic dermatitis relapses (IGA score is >=3). To assess safety, adverse event information will be collected throughout the study. Evaluations of efficacy using the IGA will occur at every study visit. Time to initial clearing and time to relapse will be summarized.

Results: Complete results will be presented in the final poster. Preliminary data shows 527 subjects with a mean age of 49.4 years enrolled and 425 have completed 26 weeks of treatment. For these subjects 304 reported at least 1 adverse event, 52 of which were considered related to the study medication. No deaths were reported and 10 subjects reported a serious adverse event. 13 subjects withdrew due to adverse events considered to be related to the study medication. The median time to clearing was 4.7 weeks and the median time to relapse after clearing was 12.0 weeks.

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