Clobex - Drug Monograph

Introduction

Clobex (clobetasol propionate) is a high-potency topical corticosteroid indicated for the short-term treatment of various inflammatory dermatoses. It is classified as a Class I super-high potency corticosteroid according to the vasoconstrictor assay system. Clobex is available in multiple formulations including spray, shampoo, lotion, and cream, providing flexibility for treating different body areas and conditions.

Mechanism of Action

Clobetasol propionate exerts its anti-inflammatory, antipruritic, and vasoconstrictive effects through binding to cytoplasmic glucocorticoid receptors. This complex then translocates to the cell nucleus where it binds to glucocorticoid response elements, resulting in:

• Inhibition of inflammatory cytokine production
• Suppression of migration of inflammatory cells
• Inhibition of phospholipase A2 activity
• Vasoconstriction of dilated blood vessels

The drug's potency is attributed to its strong receptor binding affinity and enhanced penetration through the stratum corneum.

Indications

FDA-approved indications include:

• Short-term treatment of moderate to severe plaque psoriasis
• Management of inflammatory manifestations of corticosteroid-responsive dermatoses
• Scalp psoriasis (shampoo formulation)

Additional off-label uses (based on clinical evidence):

• Lichen planus
• Discoid lupus erythematosus
• Alopecia areata
• Chronic hand eczema

Dosage and Administration

• Apply a thin layer to affected area twice daily
• Treatment duration should not exceed 2 consecutive weeks
• Total weekly dose should not exceed 50 g (or 50 mL for solution)

• Pediatric patients: Use with extreme caution; not recommended for children under 12 years
• Geriatric patients: Increased risk of systemic absorption; use minimal effective dose
• Hepatic impairment: Use with caution due to potential reduced metabolism
• Renal impairment: No specific dosage adjustment required

Pharmacokinetics

Contraindications

• Hypersensitivity to clobetasol propionate or any component of the formulation
• Rosacea
• Perioral dermatitis
• Viral skin infections (herpes simplex, varicella)
• Fungal infections at application site
• Tuberculosis of the skin

Warnings and Precautions

• Clobex can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
• May manifest as hyperglycemia, glucosuria, or Cushing's syndrome
• Systemic effects are more likely with occlusive dressings, prolonged use, or application to large body surface areas

• Risk of local skin atrophy, striae, and telangiectasia
• Increased susceptibility to skin infections
• Potential for ocular toxicity if applied near eyes
• Not for ophthalmic use
• Use caution in patients with diabetes mellitus
• May alter skin texture and pigmentation

Drug Interactions

• No formally documented drug interactions
• Theoretical increased risk of hypokalemia with potassium-wasting diuretics
• Potential enhanced effect when used with other corticosteroids
• CYP3A4 inhibitors may potentially increase systemic exposure

Adverse Effects

• Burning sensation at application site
• Pruritus
• Skin dryness
• Irritation
• Folliculitis

• HPA axis suppression
• Skin atrophy
• Striae
• Contact dermatitis
• Secondary infections
• Glaucoma (with periocular use)
• Cataracts (with prolonged use near eyes)

Monitoring Parameters

• Clinical response after 2 weeks of therapy
• Signs of HPA axis suppression (if prolonged use or large surface area)
• Local skin reactions (atrophy, striae, telangiectasia)
• Blood glucose in diabetic patients
• Signs of secondary infection
• Ophthalmic examination if used near eyes

Patient Education

• Use only as directed by healthcare provider
• Apply thin layer to affected areas only
• Avoid contact with eyes, mouth, and mucous membranes
• Do not use occlusive dressings unless directed
• Report any signs of skin irritation, infection, or lack of improvement
• Treatment course should not exceed 2 weeks without medical supervision
• Not for continuous long-term use
• Wash hands after application unless hands are treatment area
• Inform all healthcare providers about Clobex use

References

1. FDA Prescribing Information: Clobex (clobetasol propionate) 2. Wolverton SE. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier; 2021. 3. Bolognia JL, et al. Dermatology. 4th ed. Elsevier; 2018. 4. Lebwohl MG, et al. Treatment of psoriasis with clobetasol propionate foam. J Am Acad Dermatol. 2002;47(5):687-691. 5. Jarratt M, et al. Clobetasol propionate shampoo 0.05%: a new option for scalp psoriasis. J Drugs Dermatol. 2004;3(4):367-373. 6. Katz HI, et al. Superpotent topical steroid treatment of psoriasis vulgaris--clinical efficacy and adrenal function. J Am Acad Dermatol. 1987;16(4):804-811. 7. National Psoriasis Foundation. Topical treatments. Accessed [date]. https://www.psoriasis.org