Like other topical corticosteroids, clobetasol propionate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the antiinflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane

phospholipids by phospholipase A₂.

Pharmacokinetics:

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Due to the fact that circulating levels are well below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

CLINICAL STUDIES

The safety and efficacy of OLUX Foam has been demonstrated in an adequate and well-controlled clinical trial conducted in 188 patients with moderate to severe scalp psoriasis. Patients were treated twice daily for 2 weeks with OLUX Foam, vehicle foam, a commercially available clobetasol propionate solution (Temovate^® Scalp Application), or Vehicle solution. After 2 weeks of treatment, study results of the 188 patients demonstrated that the efficacy of OLUX Foam in treating scalp psoriasis was superior to that of vehicle (foam and solution), and was comparable to that of Temovate Scalp Application (see Table below).

*Defined as an Investigator's Global Assessment of "completely clear" or " almost clear," and a plaque thickness score of 0, an erythema score of 0 or 1, and a scaling score of 0 or 1 at Endpoint, scored on a severity scale of 0-4.

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