Efficacy | Lexette® Foam (halobetasol propionate)

Up to 5x more patients overall Treatment Success

clear or almost clear skin with at least a 2 grade improvement in IGA score from baseline with LEXETTE Foam compared to vehicle foam at Day 15¹

Primary endpoint

Overall Treatment Success was defined as an Investigator’s Global Assessment or IGA score ▼ of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from the baseline score at Week 2.

Overall treatment success was achieved across multiple clinical signs of plaque psoriasis at week 2¹

Secondary endpoint

Overall Treatment Success for clinical signs of plaque psoriasis (plaque elevation, scaling, and erythema) was defined as achieving a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline in individual scores assigned by investigators.

Chart showing the % of patients who achieved Treatment Success

Chart showing the % of patients who achieved Treatment Success in plaque elevation

Chart showing the % of patients who achieved Treatment Success in scaling

Chart showing the % of patients who achieved Treatment Success in erythema

Studied across a wide range of moderate to severe plaque psoriasis patients¹

LEXETTE Foam was evaluated in 2 multicenter, randomized, double-blind, vehicle-controlled clinical studies of 560 adult patients with moderate to severe plaque psoriasis involving 2%–12% body surface area (BSA).

Patients were treated with LEXETTE Foam or vehicle twice daily for up to 2 weeks (up to a maximum of 50 grams per week). The average patient randomized to the LEXETTE Foam treatment arm used 5.1 grams of LEXETTE Foam per day.

Baseline demographics

59% male/41% female
90% Caucasian/8% Black or African American/2% other race
Ages ranged from 18–85 years/Average age was 51

Disease severity characteristics at baseline

87% of patients had moderate psoriasis (IGA = 3)
13% of patients had severe psoriasis (IGA = 4)
Mean BSA affected was 5.4%

IGA Scale

Grade	Description
0	Clear	Minor residual discoloration, no erythema/scaling/plaque thickness
1	Almost clear	Occasional fine scale/faint erythema/barely perceptible
2	Mild disease	Fine scales predominate; light red coloration
3	Moderate disease	Coarse scales predominate, moderate red coloration
4	Severe disease	Thick tenacious scales predominate; deep red coloration

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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.

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