Temovate - Drug Monograph

Introduction

Temovate (clobetasol propionate) is a high-potency topical corticosteroid indicated for the short-term treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. As a Class I super-potent corticosteroid, it represents one of the most potent topical steroids available in clinical practice.

Mechanism of Action

Clobetasol propionate exerts its effects through binding to intracellular glucocorticoid receptors. This complex translocates to the cell nucleus where it binds to glucocorticoid response elements, modifying gene transcription. The drug demonstrates anti-inflammatory, antipruritic, and vasoconstrictive properties by:

• Inhibiting phospholipase A2, reducing prostaglandin and leukotriene production
• Suppressing cytokine production (IL-1, IL-2, interferon gamma)
• Stabilizing lysosomal membranes
• Reducing capillary permeability and edema
• Inhibiting migration of inflammatory cells to affected areas

Indications

FDA-approved indications:

• Short-term treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses including:

- Psoriasis (plaque-type) - Eczema - Atopic dermatitis - Lichen planus - Discoid lupus erythematosus

Off-label uses (with caution):

• Alopecia areata
• Keloids and hypertrophic scars
• Vitiligo (with phototherapy)
• Lichen sclerosus

Dosage and Administration

• Apply a thin layer to affected area twice daily
• Maximum weekly dose: 50g cream/ointment or 50mL solution
• Treatment duration: Generally limited to 2 consecutive weeks
• Occlusive dressings: Not recommended due to increased systemic absorption risk

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

Pharmacokinetics

• Percutaneous absorption depends on vehicle, skin integrity, and use of occlusive dressings
• Systemic absorption ranges from 0.5-6% through intact skin
• Increased absorption through inflamed skin, denuded areas, or with occlusion

• Binds extensively to plasma proteins (primarily albumin)
• Crosses placental barrier; detected in breast milk

• Primarily hepatic metabolism via CYP3A4
• Metabolized to inactive compounds

• Renal excretion of metabolites (40-60%)
• Biliary excretion (minor pathway)
• Elimination half-life: Approximately 3 hours

Contraindications

• Hypersensitivity to clobetasol propionate or any component of the formulation
• Rosacea
• Perioral dermatitis
• Acne vulgaris
• Cutaneous viral infections (herpes simplex, varicella, vaccinia)
• Fungal infections
• Tuberculous skin lesions
• Not for ophthalmic use

Warnings and Precautions

• Not for ophthalmic use
• May cause HPA axis suppression, Cushing's syndrome, hyperglycemia

• Use on face, groin, or axillae increases risk of local adverse effects
• Discontinue if skin irritation develops
• Avoid use in pregnancy unless potential benefit justifies potential risk
• Pediatric patients are more susceptible to systemic toxicity
• May mask symptoms of infection
• Rebound flare may occur upon discontinuation

Drug Interactions

• No formal drug interaction studies conducted
• Theoretical interactions with other corticosteroids (additive systemic effects)
• Caution with other potentially hepatotoxic drugs
• May interfere with skin testing procedures

Adverse Effects

• Burning sensation
• Pruritus
• Local irritation
• Dryness
• Folliculitis
• Hypertrichosis

• Hypothalamic-pituitary-adrenal (HPA) axis suppression
• Cushing's syndrome
• Hyperglycemia
• Glaucoma (with periocular use)
• Skin atrophy
• Striae
• Telangiectasia
• Contact dermatitis
• Secondary infections

Monitoring Parameters

• Clinical response after 2 weeks of therapy
• Signs of HPA axis suppression (if prolonged use or large surface area)
• Blood glucose in diabetic patients
• Signs of skin atrophy or other local adverse effects
• Development of secondary infections
• Pediatric growth parameters if used long-term

Patient Education

• Use only as directed by healthcare provider
• Apply thin film only to affected areas
• Avoid contact with eyes, mouth, and mucous membranes
• Do not use occlusive dressings unless specifically instructed
• Limit treatment to prescribed duration (typically ≤2 weeks)
• Report any signs of local skin reactions or infection
• Not for use on face, groin, or axillae unless specifically prescribed
• Inform all healthcare providers of Temovate use
• Store at room temperature away from moisture and heat
• Wash hands after application (unless treating hands)

References

1. FDA Prescribing Information: Temovate (clobetasol propionate) Cream and Ointment 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 Skin Disease: Comprehensive Therapeutic Strategies. 6th ed. Elsevier; 2022. 5. UpToDate: Clobetasol propionate: Drug information. Accessed January 2024. 6. Clinical Pharmacology [database online]. Tampa, FL: Elsevier; 2024.