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LEXETTE™ (halobetasol) Foam, 0.05%

LEXETTE (halobetasol propionate) Foam is a potent corticosteroid indicated for the topical treatment of plaque psoriasis in patients eighteen years of age and older.

LEXETTE Foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicentre, randomised, double-blind, vehicle-controlled studies. These studies were conducted in 560 subjects with plaque psoriasis involving between 2% and 12% body surface area. A foam vehicle can have many benefits including being absorbed quickly without residue or greasiness and being easy to apply to both hair-bearing and non-hair bearing skin.

Important Safety Information

LEXETTE Foam is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid. The potential for hypothalamic-pituitary adrenal (HPA) suppression with LEXETTE Foam was evaluated in a study of 25 adult subjects with moderate to severe plaque psoriasis involving ≥15% of their body surface area. LEXETTE Foam produced laboratory evidence of HPA axis suppression when used twice daily for two weeks in 6 out of 25 (24%) adult subjects with plaque psoriasis. Recovery of HPA axis function was generally prompt with the discontinuation of treatment.
Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.
Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including LEXETTE Foam. Some local adverse reactions may be irreversible. Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma.

For additional safety and other information, please see Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.