Tolerability & Safety | Lexette® Foam (halobetasol propionate)

Results were seen in multiple clinical trials

In randomized, multicenter, vehicle-controlled clinical trials, 351 adults with plaque psoriasis were treated with LEXETTE Foam twice daily for up to 2 weeks (up to a maximum of 50 grams per week).

Incidence of treatment-related adverse reactions in ≥1% of patients treated with LEXETTE Foam through Week 2¹

Adverse reaction	LEXETTE FOAM N=351	Vehicle Foam N=353
Application site burning/stinging	12%	15%
Application site pain	1%	<1%
Headache	1%	<1%

Skin atrophy (n=1) and telangiectasia (n=2) were reported with LEXETTE Foam, but not with vehicle foam.

Adverse reactions were mostly mild in severity¹

Patients prefer foam!

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

Patients treated with LEXETTE Foam stayed on treatment as directed*¹

treated with LEXETTE Foam discontinued treatment due to adverse reactions

who used LEXETTE Foam complied with treatment for the entire treatment period

*A patient was considered compliant with the dosing regimen if the patient applied at least 80% of expected applications and did not have any significant dosing protocol deviations.

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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) 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.

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.

Proven Tolerability and Safety through week 21

Results were seen in multiple clinical trials

Incidence of treatment-related adverse reactions in ≥1% of patients treated with LEXETTE Foam through Week 21

Adverse reactions were mostly mild in severity1