Clocortolone pivalate is a topical, medium-potency, synthetic fluorinated corticosteroid. It is used to relieve the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and psoriasis. Fluorinated corticosteroids allow for treating affected areas with thicker skin such as the palms and soles. Unlike nonfluorinated corticosteroids, clocortolone application should be avoided, if possible, on areas of thinner skin, such as the face and intertriginous areas. Clocortolone is typically recommended for short-term use only; long-term use can lead to systemic absorption.
Administration
For storage information, see the specific product information within the How Supplied section.
NOTE: If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Once control of the treated condition has been achieved, clocortolone treatment should be discontinued. Intermittent application may be needed to maintain remission or control of the treated condition. Some authorities recommend cyclic applications (i.e., 2 weeks of clocortolone treatment followed by 1 week of lubrication only) for chronic conditions like psoriasis. The lowest effective maintenance application should be used. Other options include changing to a less potent topical corticosteroid for maintenance.
Route-Specific Administration
Topical Administration
Cream/Ointment/Lotion Formulations:
-For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use. Clocortolone is not generally recommended for use on the face, groin or in the axillae.
-Restrict application to the active lesions and try to avoid normal surrounding skin.
-The amount of cream or ointment needed to cover a certain area can be calculated. A 1 g application of cream covers 100 cm2 of skin. The entire skin surface of the average size adult will be covered by 30 g of topical steroid cream.
-The manufacturer states that clocortolone may be used under an occlusive dressing for psoriasis or recalcitrant conditions. However, due to the potential for adverse systemic effects, occlusive dressings should be used cautiously.
-If clocortolone is medically necessary, do not use tight fitting diapers or plastic pants on infants, as these garments may constitute occlusive dressings.
-Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film and rub gently into affected area.
-Dry, scaly dermatoses, as occur with eczema or psoriasis, may be best treated with emollient creams, such as clocortolone pivalate.
The following adverse reactions (listed in decreasing order of occurrence) are reported with topical corticosteroids such as clocortolone and may occur more often when used with an occlusive dressing: skin irritation (including burning), pruritus, xerosis (dry skin), folliculitis, hypertrichosis, acneiform rash/eruptions, skin hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Erythema, telangiectasia, purpura, and maculopapular rash may also occur. Although skin atrophy usually occurs after prolonged use of topical corticosteroids, this effect may occur even with short-term use on intertriginous or flexor areas or on the face. If irritation develops, discontinue topical corticosteroids and institute appropriate therapy. The anti-inflammatory activity of topical corticosteroids may mask manifestations of infection. In the presence of dermatological infections, institute the use of an appropriate antifungal or antibacterial agent. If a favorable response does not promptly occur, discontinue the corticosteroid until the infection has been adequately controlled.
Signs and symptoms of corticosteroid withdrawal may occur with clocortolone dose reduction or discontinuation, and supplemental systemic corticosteroids may be needed. For example, disease flare may occur and HPA axis suppression may be present.
Systemic absorption of topical corticosteroids such as clocortolone can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after stopping treatment. In some patients, systemic absorption can produce manifestations of Cushing's syndrome, hypertension, hyperglycemia, and glycosuria. Percutaneous absorption of clocortolone is dependent on many factors including the vehicle, the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. HPA suppression and increased intracranial pressure have been reported in children receiving topical corticosteroids. Manifestations of adrenocortical insufficiency in children include linear growth inhibition, delayed weight gain, low plasma cortisol concentrations, increased intracranial pressure, and absence of response to ACTH stimulation. Clinical signs of increased intracranial pressure include bulging fontanelles, headache, and bilateral papilledema (i.e., pseudotumor cerebri). Patients applying clocortolone to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test and urinary free cortisol test). To minimize risk of HPA axis suppression, discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid.
Case reports describe visual impairment patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Clocortolone is generally not recommended for application to the eye area or for long term use. Any patient who develops changes in vision during topical application of clocortolone should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) and nonfluorinated corticosteroids have been reported to be safer for short-term use around the eye area.
In general, excessive use of corticosteroids can lead to impaired wound healing. Since clocortolone is a topical corticosteroid, it should not be applied directly or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Tolerance may occur with the prolonged use of topical corticosteroids such as clocortolone. Tolerance is usually described as a decreased acute vasoconstrictive response to the agent after a period of days to weeks. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application.
Allergic contact dermatitis with corticosteroids such as clocortolone is usually diagnosed by observing a failure to heal. Appropriate diagnostic patch testing may help with the diagnosis.
Clocortolone is contraindicated in any patient with a history of severe hypersensitivity to other corticosteroids or any ingredients in the preparation. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to clocortolone should not receive any form of clocortolone. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression and/or manifestations of Cushing's syndrome in some patients. Conditions which increase systemic absorption include application of high-potency corticosteroids, use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Topical corticosteroids should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Neonates, infants, and children may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy in children may interfere with growth and development and result in growth inhibition. If children are being treated in the diaper area, tight-fitting diapers or plastic pants should be avoided as these garments may act as an occlusive dressing and increase systemic absorption of the drug.
There are no adequate and well-controlled studies of topical application of clocortolone during pregnancy. Topical corticosteroids, including clocortolone, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Clocortolone has not been studied during breast-feeding. It is not known whether topical administration of clocortolone could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The normal inflammatory response to local infections can be masked by clocortolone. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., herpes infection, measles, varicella), should be initiated or continued only if the appropriate anti-infective treatment is instituted. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use clocortolone preparations with caution in patients with markedly impaired circulation or peripheral vascular disease; skin ulceration has been reported in these patients following topical corticosteroid use. As with other fluorinated topical corticosteroids, clocortolone should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis; clocortolone may aggravate these conditions. Clocortolone preparations should not be applied to the face, groin, or axillae. Care should be taken to avoid use around the eyes; topical preparation is not intended for ophthalmic administration. Preexisting glaucoma may be aggravated if clocortolone is used in the periorbital area.
Topical corticosteroids should be used for brief periods, or under close medical supervision in patients with evidence of pre-existing skin atrophy. Geriatric patients may be more likely to have preexisting skin atrophy secondary to aging. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients.
For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, localized vitiligo, eczema, phimosis, lichen planus, and localized bullous pemphigoid:
Topical dosage:
Adults: Apply a thin layer topically to the affected skin area(s) 3 times daily.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 3 times daily.
For the treatment of psoriasis:
Topical dosage:
Adults: Apply a thin layer topically to the affected skin area(s) 3 times daily. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 3 times daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.
Maximum Dosage Limits:
In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, dosage form selected, and patient age and response.
-Adults
3 applications/day.
-Elderly
3 applications/day.
-Adolescents
3 applications/day.
-Children
3 applications/day.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Clocortolone products.
Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.
Pharmacokinetics:
Clocortolone is applied topically as cream. It is not metabolized in the skin because clocortolone is fluorinated and also contains a substituted 17-hydroxyl group. Instead clocortolone is metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
-Route-Specific Pharmacokinetics
Topical Route
The extent of percutaneous absorption of the topical corticosteroids is dependent on many factors, including the pharmaceutical vehicle and the integrity of the epidermis. Absorption after topical application of clocortolone is increased in areas that have skin damage, inflammation, or occlusion, or in areas where the stratum corneum is thin such as the eyelids, genitalia, axillae, and face. The use of occlusive dressings with the application of clocortolone enhances penetration into the skin, and may increase the chance of systemic absorption. Anti-inflammatory effects are usually not seen for hours after clocortolone application, since the mechanism of action requires alterations in synthesis of proteins. Because clocortolone is fluorinated and also contains a substituted 17-hydroxyl group, it is not metabolized in the skin. Repeated application results in a cumulative depot effect in the skin, which may lead to a prolonged duration of action and increased systemic absorption.