Clobesol 0.05%

Description

Indications
Clobesol is prescribed for adults, the elderly, and children over the age of one for the treatment of specific dermatological conditions, including:

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions unresponsive to milder corticosteroids

Use this medication only as directed by a registered physician.

Composition

• Clobetasol Propionate Cream: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).
• Clobetasol Propionate Ointment: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).
• Clobetasol Propionate Scalp Application: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).
• Clobetasol Propionate Shampoo: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).
• Clobetasol Propionate Lotion: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).
• Clobetasol Propionate Spray: Each gram contains Clobetasol Propionate BP 0.5 mg (0.05% w/w).

Pharmacology
Clobetasol Propionate is a highly potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It works through multiple mechanisms to suppress late-phase allergic reactions, reduce mast cell density, inhibit eosinophil activation and chemotaxis, lower cytokine production, and suppress arachidonic acid metabolism.

Dosage

• Cream, Ointment: Adults, elderly, and children over one year should apply a thin layer to the affected area twice daily, gently rubbing it in. Short courses may be used to control flare-ups. In cases of resistant lesions, particularly those with hyperkeratosis, occlusion with polythene film overnight may enhance effectiveness. Treatment duration should not exceed two consecutive weeks, with a maximum dosage of 50g per week. For children, treatment should be limited to five days and monitored weekly.
• Spray: Apply to the affected scalp area once or twice daily, rubbing in gently. The total application should not exceed 50 ml per week. If no improvement is observed after one week, discontinue use.
• Shampoo: Apply once daily to dry scalp, massaging into affected areas. Leave in place for 15 minutes before lathering and rinsing. Treatment should be limited to four consecutive weeks, with a maximum dosage of 50g per week. This preparation is not recommended for individuals under 18 years of age.
• Scalp Solution: Apply once or twice daily to affected scalp areas and rub in gently. The total application should not exceed 50 ml per week. If no response is observed within a week, discontinue use.

Use this medication only as directed by a registered physician.

Administration
This medication is for cutaneous (topical) use only. Creams are best suited for moist or weeping lesions, while ointments are ideal for dry, scaly, or lichenified conditions.

Interaction
Drugs that inhibit CYP3A4, such as ritonavir and itraconazole, may reduce corticosteroid metabolism, leading to increased systemic exposure.

Contraindications
Do not use Clobesol in the following conditions:

• Rosacea, acne vulgaris, and perioral dermatitis
• Primary viral skin infections (e.g., herpes simplex, chickenpox)
• Hypersensitivity to any component of the formulation
• Fungal (e.g., candidiasis, tinea) or bacterial (e.g., impetigo) skin infections
• Perianal and genital pruritus
• Dermatoses in children under one year, including diaper rash

Side Effects
Prolonged or excessive use can lead to systemic absorption, potentially causing hypercortisolism. Localized side effects may include:

• Skin thinning, striae, and dilation of superficial blood vessels
• Pigmentation changes and excessive hair growth (hypertrichosis)
• Exacerbation of symptoms in some cases
  If hypersensitivity reactions occur, discontinue use immediately.

Pregnancy & Lactation
Limited data exist on the use of Clobetasol Propionate during pregnancy. Animal studies suggest corticosteroids may cause fetal abnormalities, but relevance to humans is unclear. Use during pregnancy or lactation should only be considered if the benefits outweigh the risks. It is unknown if this drug is excreted in human milk; therefore, caution is advised for nursing mothers.

Precautions & Warnings

• Avoid long-term continuous therapy, particularly in infants and children, due to the risk of adrenal suppression.
• Prolonged use on the face may cause atrophic changes; extra caution is required when treating psoriasis, lupus, or severe eczema.
• Avoid contact with eyes, as glaucoma or cataracts may develop.
• In psoriasis, careful monitoring is necessary due to risks such as rebound flares and systemic toxicity.
• If an infection develops, discontinue corticosteroid therapy and initiate appropriate antimicrobial treatment.

Use in Special Populations
In children under 12 years, long-term use should be avoided as they are more prone to developing atrophic skin changes.

Overdose Effects
Acute overdose is unlikely. However, chronic overuse may cause signs of hypercortisolism. If this occurs, discontinue treatment gradually.

Therapeutic Class
Other topical corticosteroids

Storage Conditions
Store below 30°C, protected from light and moisture. Do not freeze. Keep out of reach of children.