Clobetasol Propionate Foam

Indication

Olux-E (clobetasol propionate foam) Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.

Limitations of Use

• Olux-E (clobetasol propionate foam) Foam should not be applied to the face, axillae, or groin.
• Olux-E (clobetasol propionate foam) Foam should not be used if there is skin atrophy at the treatment site.
• Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.

Topically applied Olux-E (clobetasol propionate foam) Foam can be absorbed in sufficient amounts to produce systemic effects.

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.

Do not use this medication if you are allergic to clobetasol.

To make sure you can safely take clobetasol topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. It is not known whether clobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether clobetasol topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Clinical Trials Experience

In controlled clinical trials involving 821 subjects exposed to Olux-E (clobetasol propionate foam) Foam and Vehicle Foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with Olux-E (clobetasol propionate foam) Foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Olux-E (Clobetasol Propionate Foam)