Clobetasol Propionate + Salicylic Acid

• Approved Indications:
• Treatment of chronic inflammatory skin disorders with hyperkeratosis and scaling such as:
• Psoriasis (particularly plaque-type with thick scaling)
• Lichen planus
• Chronic eczema with hyperkeratosis
• Seborrheic dermatitis with scaling
• Conditions where removal of excessive keratin is necessary to enhance corticosteroid penetration and efficacy.
• Clinically Accepted Off-Label Uses:
• Hyperkeratotic lesions in other dermatoses requiring combined anti-inflammatory and keratolytic therapy.
• Treatment of palmoplantar keratoderma with inflammation.

• Adults and Adolescents (≥12 years):
• Apply a thin layer to the affected skin area once or twice daily depending on severity and physician's advice.
• Treatment duration typically limited to 2 weeks due to potency and risk of corticosteroid side effects.
• May extend up to 4 weeks in severe cases under close supervision.
• Pediatrics (<12 years):
• Use with caution and only under specialist supervision due to risk of systemic corticosteroid effects.
• Elderly:
• Use lowest effective dose and monitor for side effects.
• Special Groups (Renal/Hepatic Impairment):
• No dosage adjustment required due to topical use.
• Administration Notes:
• Topical use only.
• Avoid application on broken skin, face, groin, or under occlusive dressings unless prescribed.
• Salicylic acid may cause local irritation; start with less frequent application if sensitivity is a concern.

• Clobetasol Propionate: A super-high-potency corticosteroid that binds to intracellular glucocorticoid receptors, modulating gene expression to suppress pro-inflammatory cytokines, inhibit leukocyte infiltration, reduce edema and erythema, and provide potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
• Salicylic Acid: A keratolytic agent that promotes exfoliation by solubilizing intercellular cement, loosening and removing the stratum corneum scales and hyperkeratotic tissue. It enhances penetration of clobetasol by thinning thickened skin layers and reduces scaling.

Together, the combination reduces inflammation while simultaneously removing hyperkeratotic scales, improving drug penetration and clinical outcomes in scaling dermatoses.

• Absorption:
  Clobetasol is minimally absorbed systemically when applied topically, but absorption increases with occlusion, damaged skin, or prolonged use. Salicylic acid can enhance absorption by breaking down skin barriers.
• Distribution:
  Mostly confined to the epidermis and dermis at the site of application.
• Metabolism:
  If systemically absorbed, clobetasol undergoes hepatic metabolism. Salicylic acid is metabolized primarily in the liver if absorbed in significant quantities.
• Elimination:
  Metabolites are excreted renally.
• Half-life:
  Not clinically relevant for topical application.
• Onset:
  Anti-inflammatory effects of clobetasol typically observed within hours to days; keratolytic action of salicylic acid begins within days.

• Pregnancy:
• Clobetasol: Category C (FDA).
• Use only if clearly needed; limited systemic absorption suggests low fetal risk with topical use.
• Salicylic acid topical use in pregnancy should be cautious; high systemic absorption risk with extensive use.
• Lactation:
• Limited data. Use cautiously to avoid nipple contact during breastfeeding.
• Note: Consult healthcare provider before use in pregnancy or breastfeeding.

• Primary Therapeutic Class: Topical corticosteroid with keratolytic agent
• Subclass:
• Clobetasol Propionate: Super-high-potency corticosteroid
• Salicylic Acid: Keratolytic agent

• Known hypersensitivity to clobetasol, salicylic acid, or formulation excipients.
• Viral skin infections (e.g., herpes simplex, varicella).
• Untreated bacterial or fungal skin infections (unless combined antimicrobial therapy given).
• Acne vulgaris, rosacea, perioral dermatitis.
• Broken or ulcerated skin (unless directed by physician).
• Application to face, genitalia, or intertriginous areas unless specifically prescribed.

• Risk of skin atrophy, striae, telangiectasia with prolonged use of potent corticosteroids.
• Avoid occlusive dressings unless specifically advised.
• Salicylic acid may cause local irritation, burning, or peeling; discontinue if severe irritation occurs.
• Use cautiously in patients with impaired skin barrier to avoid systemic absorption.
• Avoid use in large quantities or on extensive skin areas.
• Monitor for secondary infections.

• Common: Local burning, stinging, dryness, irritation, peeling (due to salicylic acid).
• Less common: Skin thinning, telangiectasia, folliculitis, hypopigmentation.
• Rare: Allergic contact dermatitis, secondary skin infections, systemic corticosteroid effects with misuse.

• No significant drug-drug interactions expected with topical use.
• Avoid concurrent use with other topical corticosteroids or keratolytics unless prescribed.
• Systemic absorption of salicylic acid can theoretically interact with anticoagulants but unlikely with topical use.

• Guidelines recommend limiting use of super-potent corticosteroids to 2–4 weeks to reduce adverse effects.
• Emphasis on careful monitoring of skin integrity when combining keratolytics with potent steroids.
• Salicylic acid formulations now used cautiously on sensitive skin areas to minimize irritation.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat and moisture.
• Keep container tightly closed.
• Keep out of reach of children.