A potent, fixed-dose combination topical preparation designed for the treatment of severe, hyperkeratotic, and scaly dermatoses. It combines a super-high potency corticosteroid (clobetasol) with keratolytic agents (salicylic acid, lactic acid) and a hydrating/humectant agent (urea). This synergistic formulation targets inflammation, pruritus, hyperkeratosis, and xerosis simultaneously, making it particularly effective for conditions like psoriasis and chronic eczema with significant scaling.
Adult: Apply a thin film to the affected area once or twice daily, as directed by the physician. For plaque psoriasis and severe eczema, once-daily application is often sufficient. Treatment should be limited to 2 consecutive weeks. The total weekly dose should not exceed 50 grams.
Note: 1. Wash and dry the affected area gently. 2. Apply a thin layer and rub in gently until absorbed. 3. Do not apply on broken skin, near eyes, mouth, or mucous membranes. 4. Do not bandage, wrap, or cover the treated area with airtight dressings (occlusion) unless specifically advised by the doctor, as this dramatically increases absorption and side effects. 5. Wash hands after application unless hands are the treatment site.
The combination exerts a multi-pronged therapeutic action. Clobetasol, a super-potent glucocorticoid receptor agonist, binds to intracellular receptors, modulating gene transcription to produce profound anti-inflammatory, immunosuppressive, antiproliferative, and vasoconstrictive effects. Salicylic acid acts as a keratolytic by disrupting intercellular cohesion in the stratum corneum, facilitating desquamation of hyperkeratotic skin. Lactic acid, an alpha-hydroxy acid, acts as a humectant and keratolytic by reducing corneocyte adhesion and increasing hydration. Urea is a potent humectant and keratolytic; at 10% concentration, it hydrates the stratum corneum by breaking hydrogen bonds, softening hyperkeratosis, and enhancing penetration of other active ingredients.
Pregnancy: Pregnancy Category C (US FDA). Topical corticosteroids, especially potent ones, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show teratogenicity with corticosteroids. Not recommended for extensive use, long duration, or under occlusion. Avoid use on breasts prior to nursing.
Driving: No known effects on driving ability.
| Other Topical Corticosteroids | Additive risk of local and systemic side effects, including HPA axis suppression. | Major |
| Oral Anticoagulants (e.g., Warfarin) | Salicylic acid may potentiate anticoagulant effect by displacing warfarin from protein binding sites and inhibiting platelet function, increasing bleeding risk. | Moderate |
| Methotrexate | Salicylic acid may decrease renal excretion of methotrexate, increasing risk of methotrexate toxicity (myelosuppression, hepatotoxicity). | Major |
| Oral Hypoglycemics/Insulin | Clobetasol can cause hyperglycemia, antagonizing the effect of hypoglycemic agents. Salicylic acid in high doses can also lower blood glucose. | Moderate |
| Diuretics (e.g., Furosemide) | Clobetasol can cause sodium and water retention, counteracting diuretic effect. | Moderate |
| Live Vaccines | Immunosuppressive effect of clobetasol may impair antibody response and increase risk of vaccine-induced infection. | Major |
Same composition (Clobetasol (0.05% w/w) + Salicylic Acid (3% w/w) + Lactic Acid (3% w/w) + Urea (10% w/w)), different brands: