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

vehicle of the study product at week 52 or ET. The questionnaire asked subjects to evaluate the study-product delivery system (ie, the foam vehicle) relative to other product forms or types (ie, gels, creams, ointments, and shampoos) that they had used previously to treat seborrheic dermatitis. The questionnaire did not ask subjects to evaluate the efficacy of the study product. The questionnaire specifically included the following items: what types of products have you ever used to treat your seborrheic dermatitis; rank the product types from 1 (product type you prefer most) to 5 (product type you prefer least); rank the product types from 1 to 5 on ease of use, speed of absorption, versatility, and overall preference.

The safety analysis population was defined as all subjects who received at least one application of the study product.

The primary end point was the long-term safety of ketoconazole foam, 2%, applied twice daily as needed for up to 12 months in the treatment of seborrheic dermatitis. Efficacy of ketoconazole foam, 2%, was evaluated according to erythema, scaling, and pruritus assessments, and ISGA score of the target lesion.

A sample size of 500 subjects was originally planned for enrollment in order to obtain ≥300 and ≥100 evaluable subjects at 6 months and 12 months, respectively, to provide long-term safety information on the use of ketoconazole foam, 2%. No power calculation was performed. Statistical analyses were performed using the safety analysis population, and descriptive statistics were used to provide an overview of all evaluation endpoints. Data from all investigational centers were combined in the calculations, unless otherwise stated.

All statistical analyses were performed using SAS software (version 9.1.3; SAS Institute Inc, Cary, NC). Safety variables were tabulated using observed data only; no imputations were made for missing data.

A total of 500 subjects were recruited. Of these, 498 subjects were included in the safety population (2 subjects did not apply the study product), and 363 subjects completed the 12-month study (Figure 1). The most common reasons for study discontinuation were loss to follow-up (41%; 55/135 who discontinued) or withdrawal of consent (30%; 40/135). Subjects were predominantly white (69%; 346/498) and 18 to 65 years of age (81%; 402/498; Table 1). The most common areas affected by seborrheic dermatitis were the face (70%; 347/498) and scalp (86%; 430/498). Target lesions were also most commonly located on the face (43%; 214/498) and scalp (51%; 252/498).

Adverse Events
The majority of subjects (69%; 341/498) applied ketoconazole foam, 2%, for 39 weeks or more, and 48% (238/498) used the study product for at least 50 weeks. Overall, 57% (282/498) of subjects experienced at least one AE. Subjects most commonly reported