Olux-E

Olux-E

CLINICAL PHARMACOLOGY

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.

The contribution to efficacy by individual components of the vehicle has not been established.

Pharmacodynamics

In a study evaluating the potential for HPA axis suppression, using the cosyntropin stimulation test, Olux-E (clobetasol propionate foam) Foam demonstrated reversible adrenal suppression after two weeks of twice daily use in patients with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects twelve years of age and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this study HPA axis suppression was defined as serum cortisol level ≤ 18 mcg/dL 30-min post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment. [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]

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 product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Following twice daily application of Olux-E (clobetasol propionate foam) Foam for one week to 32 adult patients with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post-dose on day 8.

Clinical Studies

In a randomized study of subjects 12 years of age and older with moderate to severe atopic dermatitis, 251 subjects were treated with Olux-E (clobetasol propionate foam) Foam and 126 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 131 of 251 subjects (52%) treated with Olux-E (clobetasol propionate foam) Foam compared with 18 of 126 subjects (14%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation.

In an additional randomized study of subjects 12 years of age and older with mild to moderate plaque-type psoriasis, 253 subjects were treated with Olux-E (clobetasol propionate foam) Foam and 123 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 41 of 253 subjects (16%) treated with Olux-E (clobetasol propionate foam) Foam compared with 5 of 123 subjects (4%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.

Last reviewed on RxList: 12/16/2010
This monograph has been modified to include the generic and brand name in many instances.

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Olux-E - User Reviews

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