Lexette - Drug Monograph

Introduction

Lexette™ (halobetasol propionate) foam, 0.05% is a high-potency topical corticosteroid formulation developed for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. This innovative foam delivery system provides enhanced patient acceptability and targeted application for various dermatological conditions.

Mechanism of Action

Halobetasol propionate, the active ingredient in Lexette, is a synthetic corticosteroid classified as a Class I super-high potency topical steroid. It exerts its therapeutic effects through:

• Binding to cytoplasmic glucocorticoid receptors
• Modulating gene expression through inhibition of inflammatory mediators
• Suppressing migration of polymorphonuclear leukocytes
• Reducing capillary permeability and edema
• Inhibiting cytokine production (IL-1, IL-2, interferon gamma, TNF-α)

The drug demonstrates vasoconstrictive, anti-inflammatory, antipruritic, and immunosuppressive properties through these mechanisms.

Indications

FDA-approved indications:

• Treatment of plaque psoriasis in patients 18 years and older
• Management of corticosteroid-responsive dermatoses

Off-label uses (based on clinical experience):

• Atopic dermatitis
• Lichen planus
• Lichen sclerosus
• Other inflammatory dermatoses requiring high-potency corticosteroid therapy

Dosage and Administration

• Apply a thin layer to affected areas twice daily
• Gently rub into the skin until foam disappears
• Use the smallest amount necessary to control symptoms

• Limited to 2 consecutive weeks
• Total weekly dosage should not exceed 50 grams
• Not recommended for use beyond 2 weeks without medical supervision

• Geriatric patients: Use with caution due to increased skin fragility
• Pediatric patients: Safety and effectiveness not established
• Hepatic impairment: No specific dosage adjustment recommended
• Renal impairment: No specific dosage adjustment recommended

Pharmacokinetics

• Systemic absorption varies based on application site, skin integrity, and use of occlusive dressings
• Greater absorption occurs through broken skin or inflamed areas

• Binds extensively to plasma proteins
• Distributed throughout body tissues

• Primarily hepatic metabolism via conjugation and oxidation
• Forms inactive metabolites

• Renal excretion of metabolites
• Elimination half-life approximately 2-3 hours
• No accumulation observed with appropriate use

Contraindications

• Hypersensitivity to halobetasol propionate or any component of the formulation
• Viral skin infections (herpes simplex, varicella)
• Fungal skin infections
• Bacterial skin infections without appropriate antimicrobial therapy
• Use on rosacea, perioral dermatitis, or acne

Warnings and Precautions

• Reversible HPA axis suppression may occur with prolonged use
• Potential for hyperglycemia, glucosuria, Cushing's syndrome
• More likely with large surface area applications, prolonged use, or occlusive dressings

• Skin atrophy, striae, telangiectasia may occur
• Contact dermatitis possible
• Increased risk of secondary infections

• Avoid use on face, groin, or axillae unless directed by physician
• Discontinue if irritation develops
• Not for ophthalmic use
• Use with caution in patients with skin conditions that may increase systemic absorption

Drug Interactions

• Other topical products that may enhance absorption or cause irritation
• Systemic corticosteroids (additive systemic effects)
• Drugs that affect corticosteroid metabolism (e.g., ketoconazole, erythromycin)

Adverse Effects

• Application site reactions (burning, stinging, itching)
• Dry skin
• Folliculitis
• Erythema

• HPA axis suppression
• Visual disturbances (cataracts, glaucoma)
• Skin atrophy and striae
• Secondary infections
• Allergic contact dermatitis
• Hypopigmentation

Monitoring Parameters

• Improvement in erythema, scaling, and induration
• Reduction in pruritus and inflammation

• Signs of HPA axis suppression (fatigue, weakness, nausea, hypotension)
• Local skin reactions (atrophy, telangiectasia, striae)
• Signs of secondary infection
• Blood pressure and blood glucose in prolonged use
• Growth monitoring in pediatric patients (if used off-label)

Patient Education

• Apply only to affected areas as directed
• Wash hands before and after application
• Do not cover treated area unless directed by physician
• Avoid contact with eyes, mouth, and mucous membranes

• Use only for prescribed duration (maximum 2 weeks)
• Report any signs of skin irritation or infection
• Do not use on children unless specifically prescribed
• Inform all healthcare providers about Lexette use
• Store at room temperature away from heat and flame
• The foam is flammable—avoid fire, flame, or smoking during and immediately after application

• No improvement after 2 weeks of treatment
• Worsening of condition
• Signs of infection (pus, increased redness, pain)
• Symptoms of systemic absorption (weight gain, fatigue, muscle weakness)

References

1. FDA prescribing information: Lexette (halobetasol propionate) foam, 0.05%. Revised 2021. 2. Lebwohl MG, Heymann WR, Coulson IH, et al. Treatment of plaque psoriasis with halobetasol propionate foam 0.05%. J Drugs Dermatol. 2019;18(2):168-174. 3. Draelos ZD, Feldman SR, Berman B, et al. Halobetasol propionate foam 0.05%: A novel vehicle for the treatment of corticosteroid-responsive dermatoses. J Clin Aesthet Dermatol. 2019;12(5):27-32. 4. Jorizzo JL, Lebwohl M, Tobey RE. The efficacy and safety of halobetasol propionate foam 0.05% in the treatment of moderate to severe plaque psoriasis. J Clin Aesthet Dermatol. 2019;12(3):27-32. 5. Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol. 2005;53(1 Suppl 1):S50-58. 6. Wolverton SE. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier; 2020.