Long-term Safety of Ketoconazole Foam, 2% in the Treatment of Seborrheic Dermatitis: Results of a Phase IV, Open-Label Study

of 2 to 4 at baseline and a discrete, evaluable target lesion of at least 0.5 cm² with a score of 2 to 4 for erythema and scaling on the seborrheic dermatitis grading scale. Exclusion criteria included use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks before baseline; use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, scalp, ears, neck, or chest within 2 weeks before baseline; use of any investigational drugs other than the study product within 4 weeks before baseline or during the study period; use of any medication that, in the investigator’s opinion, may have affected the evaluation of the study product or placed the subject at undue risk; intolerance to ketoconazole or its excipients; female subjects who were pregnant, trying to become pregnant, or lactating; any clinically relevant abnormal vital signs or findings in the physical examination; any clinically relevant history of alcohol or drug abuse; major illness within 30 days before baseline; immunocompromisation; or any clinically significant condition that would compromise the subject’s participation in the study.

All subjects attended up to 7 study visits over a 52-week period. At baseline (day 1), all subjects signed and dated an informed consent document, were evaluated against the inclusion/exclusion criteria, provided their medical history, and were given a diary card and ketoconazole foam, 2%, with application instructions. Subjects applied ketoconazole foam, 2%, topically in the morning and evening to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest at the first sign of a symptom flare, until the treatment areas cleared. All symptom flares were treated throughout the 12-month study period.

At all study visits (baseline, weeks 4, 8, 16, 26, 39, and 52 or early termination [ET]), subjects provided concomitant medication information, vital signs were measured, and target lesions were evaluated by the investigator for erythema, scaling, and pruritus (on individual scales of 0 to 4, no/mild symptoms to severe symptoms) and ISGA score (on a scale of 0 to 4 based on erythema and scaling scores, where the higher score indicates more severe symptoms). Used study product containers and completed diary cards were returned and replaced at each study visit except week 52 or ET. Used study product containers were weighed before dispensing and after collection, and subjects were questioned regarding their compliance with study-product application at each study visit. Every observed and reported adverse event (AE) was recorded at all postbaseline study visits. Blood and urine samples were collected at baseline and at weeks 8, 26, and 52 (or ET) for clinical laboratory analyses. At baseline and at week 52 (or ET), subjects received a physical examination and females of childbearing potential completed a pregnancy test. Subjects completed a poststudy questionnaire to collect information regarding their impressions of the foam