About LEXETTE Foam | Lexette® Foam (halobetasol propionate)

Many plaque psoriasis patients are frustrated with their topical vehicle¹

When choosing a treatment for plaque psoriasis, patients rated the following topical attributes as extremely important or important*:

*135 patients with plaque psoriasis were asked to rate the acceptability of product administration and overall treatment experience by answering questions from a survey.¹

LEXETTE Foam has what patients look for¹

Not greasy or sticky
Dries quickly
Leaves no residue
Easy to apply to plaques, including large body surface, hair-bearing, and non-hair-bearing areas

Maintains consistency to allow sufficient time to apply
Lightweight and airy
Free of fragrances and parabens

When I put on ointment at night and don’t give it ample time to dry—I feel like I am sliding around in greasy sheets when I’m trying to sleep.

Moderate psoriasis patient

Satisfaction with the vehicle may lead to improved patient compliance¹

In 2 studies of 659 plaque psoriasis patients, 86% said they would comply with a foam treatment 75%–100% of the time.¹

A closer look at the formulation of LEXETTE Foam²

Ingredient name	Function
Halobetasol propionate (corticosteroid)	Active ingredient
Alcohol, denatured (SDA 40B)	Solvent for halobetasol Carrier of halobetasol for drug delivery
Benzoic acid	Can corrosion inhibitor
Cetostearyl alcohol	Foam-structuring agent: Emulsion stabilizer Opacifying agent Surfactant foam booster Emollient
Emulsifying wax	Foam-structuring agent: Emulsifier
Polyoxyl 20 cetostearyl ether	Foam-structuring agent: Non-ionic emulsifier
Propylene glycol (only 5%)	Humectant (hydrating) Stabilizer Drug delivery/penetration enhancer Emollient
Purified water	Base diluent
Hydrocarbon (isobutane/propane) propellant	Propellant

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Indication

LEXETTE^® Foam (halobetasol propionate) is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

Important Safety Information

LEXETTE^® Foam (halobetasol propionate) 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.

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.

Discover the elegance and convenience of new LEXETTE Foam

Many plaque psoriasis patients are frustrated with their topical vehicle1

LEXETTE Foam has what patients look for1

Satisfaction with the vehicle may lead to improved patient compliance1

A closer look at the formulation of LEXETTE Foam2