Ketoconazole Foam, 2%

Mechanism Of Action

The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.

Pharmacodynamics

The pharmacodynamics of EXTINA® Foam has not been established.

Pharmacokinetics

In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of EXTINA® Foam twice daily for 4 weeks. Circulat­ing plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject.

Microbiology

Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur. The clini­cal significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Clinical Studies

The safety and efficacy of EXTINA® Foam were evaluated in a random­ized, double-blind, vehicle-controlled study in subjects 12 years and older with mild to severe seborrheic dermatitis. In the study, 427 subjects received EXTINA® Foam and 420 subjects received vehicle foam. Subjects applied EXTINA® Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator's Static Global Assessment (ISGA) scale.

Treatment success was defined as achieving a Week 4 (end of treat­ment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Table 2: Efficacy Results

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

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