ACLOVATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ACLOVATE (ACLOVATE).
Aclovate (alclometasone dipropionate) is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism involves binding to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reducing arachidonic acid release, and decreasing prostaglandin and leukotriene synthesis.
| Metabolism | Aclovate is metabolized in the skin and liver via ester hydrolysis to inactive metabolites. Systemic metabolism primarily involves cytochrome P450 enzymes (CYP3A4) for any absorbed fraction, but extensive first-pass metabolism limits systemic exposure. |
| Excretion | Renal (primarily as metabolites, <5% unchanged), biliary/fecal (minor). |
| Half-life | Terminal elimination half-life: approximately 6-8 hours after topical application; systemic absorption is minimal under normal use. |
| Protein binding | Approximately 90%, primarily to albumin and corticosteroid-binding globulin (CBG). |
| Volume of Distribution | Not well-characterized in topical use; after systemic absorption, Vd is approximately 1-2 L/kg, indicating distribution into tissues. |
| Bioavailability | Topical: approximately 1-3% systemic absorption on intact skin; increased up to 15% on occluded or damaged skin. |
| Onset of Action | Topical: symptomatic relief within 24-48 hours of application. |
| Duration of Action | Topical: effect persists for 12-24 hours after a single application; clinical improvement continues with regular use. |
Apply a thin film to affected skin areas twice daily. Not for ophthalmic, oral, or intravaginal use.
| Dosage form | OINTMENT |
| Renal impairment | No dose adjustment required. Topical use with minimal systemic absorption. |
| Liver impairment | No dose adjustment required. Topical use with minimal systemic absorption. |
| Pediatric use | Use smallest amount effective for shortest duration. Avoid prolonged use, occlusive dressings, or application to large surface areas. Safety in children <1 year not established. |
| Geriatric use | Use with caution due to increased risk of skin atrophy and systemic absorption. Limit frequency and duration; avoid occlusive dressings. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ACLOVATE (ACLOVATE).
| Breastfeeding | Safety unknown; likely minimal systemic absorption due to low potency. M/P ratio not established. Avoid application to breasts or large areas; use caution. |
| Teratogenic Risk | Topical corticosteroids like ACLOVATE (alclometasone dipropionate) are generally considered low risk in pregnancy, but systemic absorption can occur. Class C: Fetal risk cannot be ruled out. Avoid extensive use or prolonged treatment, especially in first trimester. Second and third trimester: Use only if clearly needed, minimal area and duration. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to alclometasone dipropionate or any component of the formulation.","Untreated bacterial, fungal, or viral skin infections (e.g., herpes simplex, varicella, tuberculosis of the skin)."]
| Precautions | ["Topical corticosteroids can cause hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with prolonged use, large surface area, occlusion, or in pediatric patients.","Reversible HPA axis suppression may occur after discontinuation.","Systemic effects including Cushing's syndrome, hyperglycemia, and glucosuria have been reported.","Local adverse reactions: burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, maceration, secondary infection, skin atrophy, striae, and miliaria.","Use caution in patients with impaired skin integrity or areas of skin atrophy.","Pediatric patients may be more susceptible to systemic toxicity due to higher skin surface-to-body-weight ratio."] |
| Food/Dietary | No known food interactions with topical Aclovate. |
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| Fetal Monitoring |
| Monitor maternal skin integrity, signs of local or systemic adverse effects (e.g., skin atrophy, adrenal suppression). Fetal monitoring not required unless extensive use. |
| Fertility Effects | No known effects on fertility from topical alclometasone; systemic corticosteroids may impair fertility, but topical use minimal. |
| Clinical Pearls | Topical corticosteroids like Aclovate are classified as low-potency (Group VI). They are suitable for thin skin areas (e.g., face, flexures) and for children. Avoid prolonged use without interruption to minimize systemic absorption, especially in pediatric patients due to higher skin surface area-to-body weight ratio. |
| Patient Advice | Apply a thin layer to affected skin only, not to normal surrounding skin. · Do not cover with bandages or dressings unless directed by your doctor. · Use for the prescribed duration; do not use longer than 2 weeks at a time. · Avoid contact with eyes, mouth, and open wounds. · Report any signs of skin thinning, redness, or irritation to your healthcare provider. |