Version May 2024
Steroid-responsive dermatoses: Topical: Apply sparingly to the affected area 3 times daily. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.
Note: May use occlusive dressings for the management of psoriasis or recalcitrant conditions. If infection develops, discontinue occlusive dressing and institute appropriate antimicrobial therapy.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Clocortolone: Pediatric drug information")
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time to avoid hypothalamic-pituitary-adrenal (HPA) axis suppression. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Children and Adolescents: Cream 0.1%: Topical: Apply sparingly to the affected area 3 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no adverse reactions listed in the manufacturer's labeling.
Postmarketing:
Dermatologic: Secondary skin infection (Singh 2012), skin blister (Singh 2012), stinging of the skin (application site) (Del Rosso 2012)
Local: Application-site burning (Del Rosso 2012), application-site irritation (Singh 2012), application-site pruritus (Del Rosso 2012), local dryness of skin (application site) (Del Rosso 2012)
Hypersensitivity to clocortolone or any component of the formulation.
Concerns related to adverse effects:
• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Contact dermatitis: Allergic contact dermatitis can occur; it is usually diagnosed by failure to heal rather than clinical exacerbation.
• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).
• Immunosuppression: Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.
• Ocular effects: Topical corticosteroids, including clocortolone, may increase the risk of posterior subcapsular cataracts and glaucoma. Monitor for ocular changes. Avoid contact with eyes.
• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
• Older adult: Because of the risk of adverse effects associated with systemic absorption, topical corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration.
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
The extent of percutaneous absorption is dependent on several factors, including epidermal integrity (intact vs abraded skin), formulation, age of the patient, duration of use, and the use of occlusive dressings. Percutaneous absorption of topical steroids is increased in neonates (especially preterm neonates), infants, and young children. Infants and small children may be more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression, intracranial hypertension, Cushing syndrome, or other systemic toxicities due to larger skin surface area to body mass ratio.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as pivalate:
Cloderm: 0.1% (45 g, 75 g, 90 g) [contains edetate (edta) disodium, methylparaben, propylparaben]
Generic: 0.1% (45 g, 75 g, 90 g)
Yes
Cream (Clocortolone Pivalate External)
0.1% (per gram): $7.17
Cream (Cloderm External)
0.1% (per gram): $9.52
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: For external use only; not for intravaginal, ophthalmic, or oral use. Avoid contact with eyes. Apply to clean, dry skin and rub in gently. Unless otherwise directed by health care professional, do not use with occlusive dressing.
Topical: Apply sparingly to affected areas. Unless otherwise directed by health care professional, do not use occlusive dressings (including diapers or plastic pants if treating diaper area); in some cases, occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If infection develops, discontinue occlusive dressing and institute appropriate antimicrobial therapy. Wash hands after use. For external use only; not for intravaginal, ophthalmic, or oral use; avoid contact with eyes.
Steroid-responsive dermatoses: Treatment of inflammation and pruritus of corticosteroid-responsive dermatoses (intermediate-potency topical corticosteroid)
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
Cloderm: Brand name for clocortolone [US, Canada], but also brand name for alclometasone [Indonesia]; clobetasol [China, India, Malaysia, Singapore, Thailand]; clotrimazole [Germany]
None known.
There are no known significant interactions.
Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).
Systemic bioavailability of topical corticosteroids is variable (integrity of skin, use of occlusion, etc) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low-birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).
When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).
It is not known if topical application will result in detectable quantities in breast milk. However, systemic corticosteroids are excreted in human milk.
Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).
Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding then clean nipples prior to the next feeding (Vestergaard 2019)
Adrenal suppression with extensive/prolonged use (adrenocorticotropic hormone stimulation test, morning plasma cortisol test, urinary free cortisol test); response to treatment; ocular changes.
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Clocortolone has intermediate range potency.
Absorption: Percutaneous absorption is variable and dependent upon many factors including vehicle used, integrity of epidermis, dose, and use of occlusive dressings; small amounts enter circulatory system via skin
Metabolism: Hepatic
Excretion: Urine and feces
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