Long-term Safety of Ketoconazole Foam, 2% in the Treatment of Seborrheic Dermatitis: Results of a Phase IV, Open-Label Study
January 2013 | Volume 12 | Issue 1 | Original Article | e1 | Copyright © 2013
Zoe D. Draelos MD a, Steven R. Feldman MD PhD b, Victoria Butners BSc c, and Alessandra B. Alió Saenz MD c
aDepartment of Dermatology, Duke University School of Medicine, Durham, NC bDepartment of Dermatology, Wake Forest University, Winston-Salem, NC cStiefel, a GlaxoSmithKline (GSK) company, Research Triangle Park, NC
Background: Ketoconazole foam, 2%, is approved in the United States for seborrheic dermatitis therapy in immunocompetent patients aged ≥12 years. While short-term trials have demonstrated its safety and efficacy, seborrheic dermatitis often requires long-term treatment.
Objective: To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
Methods: A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
Results: Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
Limitations: Evaluation of severity was limited to target lesion; no objective measure of adherence.
Conclusion: The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained. This trial was registered at clinicaltrials.gov (NCT00703846).
J Drugs Dermatol. 2013;12(1):e1-e6.
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Seborrheic dermatitis is a multifactorial, recurrent inflammation of the skin that presents as pruritic, erythematous, scaly patches most commonly occurring in sebum-rich areas such as the face, scalp, and chest.1 An inflammatory response against Malassezia species, opportunistic fungal pathogens that are normally present as skin commensals, underlies the etiology of the disease.2,3
Topical antifungal agents are the most common treatment for recurrent seborrheic dermatitis4,5 and are not often associated with the skin atrophy or telangiectasia seen with prolonged use of topical corticosteriods.2 Topical ketoconazole, 2%, an imidazole derivative active against species of Malassezia, has been approved in the United States as a cream since 1985 and as a shampoo since 1990. In 2007, ketoconazole foam, 2%, was approved in the United States for the topical treatment of seborrheic dermatitis when used twice daily for 4 weeks in immunocompetent patients 12 years and older. The vehicle used to deliver topical agents in dermatology can have a considerable effect on efficacy, and foam vehicles have advantages over creams, ointments, and solutions in drug bioavailability.6,7 In addition, the cosmetic aspects of a foam delivery system, eg, nongreasy and low residue, may be associated with increased patient adherence,6 particularly in hair-bearing areas, as commonly occurs in seborrheic dermatitis.
The objective of this study was to assess the long-term safety of ketoconazole foam, 2%, applied twice daily, as required, for up to 12 months in the treatment of seborrheic dermatitis.
This was an open-label, multicenter study to assess the long-term safety of ketoconazole foam, 2%, (Extina®; Stiefel, a GSK Company, Research Triangle Park, NC) in the treatment of seborrheic dermatitis (NCT00703846). Patients were recruited from 18 investigational centers in the United States between June 2008 and April 2010. The study was performed in accordance with Good Clinical Practice (ICH Topic E6) and the guiding principles of the Declaration of Helsinki and had institutional review board approval.
Subjects 12 years or older were eligible to participate if they had seborrheic dermatitis on the face, scalp, ears, neck, or chest with an Investigator's Static Global Assessment (ISGA) score