Brand names: Clobevate, Clobex, Cormax, Embeline, Olux, Temovate
Drug class: Corticosteroids
VA class: DE200
Chemical name: (11-β,16β)-21-Chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione
Molecular formula: C₂₅H₃₂ClFO₅
CAS number: 25122-46-7

Medically reviewed by Drugs.com on Jan 19, 2024. Written by ASHP.

Introduction

Synthetic fluorinated corticosteroid.

Uses for Clobetasol

Corticosteroid-responsive Dermatoses

Short-term relief of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp.

Generally most effective in acute or chronic dermatoses (e.g., seborrheic or atopic dermatitis, localized neurodermatitis, anogenital pruritus, psoriasis, late phase of allergic contact dermatitis, inflammatory phase of xerosis).

Topical therapy generally preferred over systemic therapy; fewer associated adverse systemic effects.

Topical therapy generally only controls manifestations of dermatoses; eliminate cause if possible.

Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy. (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.

Cream, ointment, gel, lotion, shampoo, and foam (0.05% clobetasol propionate) are considered to have high-range potency.

Not to be used in the treatment of rosacea or perioral dermatitis. Topical corticosteroids generally should not be used in the treatment of acne or as monotherapy in the treatment of widespread plaque psoriasis.

Related/similar drugs

Rinvoq, Taltz, prednisone, doxycycline, methotrexate, triamcinolone, Humira

Clobetasol Dosage and Administration

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.

• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.

• Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin). Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol). (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes. If such contact occurs, flush affected eye(s) with copious amounts of water.

Do not apply to the face or intertriginous areas (e.g., axilla, groin).

Cream, ointment, gel, or solution containing clobetasol propionate not intended for ophthalmic, oral, or intravaginal use.

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.

Apply cream, ointment, gel, lotion, or foam sparingly in a thin film and rub gently into affected area.

To apply foam, invert canister; dispense a small amount (up to a maximum of a golf-ball-sized dollop or 1 1/2 capfuls) of foam into the cap of the canister, onto cool surface (e.g., saucer), or directly on the lesion, taking care to avoid contact with the eyes. Foam will begin to melt immediately upon contact with warm skin; do not dispense directly onto hands (unless the hands are the affected area). If the canister seems warm to the touch or the foam seems runny, place the canister under cold running tap water. Using clean, dry fingertips, gently massage foam into the affected area; repeat until the entire affected area has been treated. Avoid exposure to flames or smoking during and immediately after application.

Apply solution to affected areas of the scalp.

Apply shampoo onto dry scalp; leave for 15 minutes before washing and rinsing; avoid contact with lips.

After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.

Administration with Occlusive Dressing

Manufacturers state that the cream, gel, ointment, or solution should not be used with occlusive dressings. However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of lotion, shampoo, or foam preparations. (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of the corticosteroid preparation; rub gently into the lesion; and apply another thin film. Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape. For added moisture in dry lesions, apply the corticosteroid preparation and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of clobetasol proprionate are essential at each dressing change.

Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed. Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion. (See Occlusive Dressings under Cautions.)

Dosage

Available as clobetasol propionate; dosage expressed in terms of the salt.

Intermittent maintenance therapy, such as administration of the drug once or twice weekly for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy. (See Pediatric Use under Cautions.)

Corticosteroid-responsive Dermatoses

Topical

Children ≥12 years of age: Apply cream, ointment, gel, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.

Adults

Corticosteroid-responsive Dermatoses

Topical

Apply cream, ointment, gel, lotion, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.

Emollient cream or lotion (applied to no more than 10% of body surface area) may be used for up to 4 consecutive weeks in the management of plaque psoriasis; however, the manufacturers state that additional benefits of extended treatment (i.e., >2 weeks) should be weighed against the risk of HPA-axis suppression. (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Apply shampoo to scalp once daily. Discontinue when control is achieved. If improvement does not occur within 4 weeks, consider reassessment of the diagnosis and consider substituting a less potent topical corticosteroid preparation.

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Topical

Maximum 50 g of 0.05% cream, ointment, or gel per week for no more than 2 consecutive weeks.

Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.

Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.

Adults

Corticosteroid-responsive Dermatoses

Topical

Maximum 50 g of 0.05% cream, ointment, gel, or lotion per week for no more than 2 consecutive weeks.

Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.

Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.

In patients with plaque psoriasis, maximum 50 g of 0.05% emollient cream, shampoo, or lotion per week for no more than 4 consecutive weeks.

In patients with psoriasis of the scalp, maximum 4 consecutive weeks of therapy with shampoo.

Special Populations

Geriatric Patients

No dosage adjustments with cream, ointment, gel, or solution. Titrate dosage carefully when using foam, lotion, or shampoo; initiate therapy at the low end of the dosage range.

Cautions for Clobetasol

Contraindications

• Known hypersensitivity to clobetasol propionate, other corticosteroids, or any ingredient in the formulation.

• Primary infections of the scalp (clobetasol propionate solution).

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.

Major Toxicities

Risk of Systemic Effects with Highly Active Preparations

Clobetasol propionate is a potent topical corticosteroid and can be absorbed in sufficient amounts to produce systemic effects, including HPA-axis suppression. (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis. HPA-axis suppression has occurred following topical dosages as low as 2 g of the 0.05% ointment or cream (1 mg of clobetasol propionate total) or 7 g of the 0.05% foam (3.5 mg of clobetasol propionate total) daily.

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.

HPA-axis function recovery generally is prompt and complete following drug discontinuance.

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Risk of adverse systemic effects increases with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.

Infants and children may be more susceptible to adverse systemic effects. (See Pediatric Use under Cautions.)

Local Effects

Possible adverse local reactions (e.g., irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue; these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas. Do not apply to the face or intertriginous areas.

If irritation occurs during treatment, discontinue drug and institute appropriate therapy.

Skin Infections

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy. If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation. In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.

Do not use occlusive dressings in patients with primary skin infection.

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin); however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.

Occlusive Dressings

Certain topical clobetasol propionate preparations (cream, gel, ointment, solution) should not be used with occlusive dressings.

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly. (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy. (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.

Do not use occlusive dressings in patients with primary skin infection.

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.

Use plastic occlusive material with care to avoid the risk of suffocation.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether topical clobetasol is distributed into milk. Caution advised if topical clobetasol is used.

Pediatric Use

Use of clobetasol propionate cream, ointment, solution, foam, or gel not recommended in children <12 years of age.

Use of clobetasol propionate lotion or shampoo not recommended in children <18 years of age.

Use of clobetasol propionate emollient cream not recommended in children <12 years of age; use beyond 2 consecutive weeks has not been evaluated in children <16 years of age.

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio, especially when topical corticosteroids are applied to >20% of body surface area. The risk of adrenal suppression appears to increase with decreasing age. (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.

Children also are at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment.

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.

Striae have been reported in children treated inappropriately with topical corticosteroids.

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic effect; chronic topical corticosteroid therapy may interfere with growth and development.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether safety and efficacy of clobetasol propionate cream, ointment, gel, foam, lotion, or solution in geriatric patients differ from safety and efficacy in younger adults.

Common Adverse Effects

Burning, stinging, irritation, itching, skin atrophy, dry skin, cracking or fissuring of the skin, erythema, folliculitis, numbness of fingers, tenderness in the elbow, telangiectasia.

Clobetasol propionate solution or shampoo: pustules on the scalp, tingling, folliculitis, tightening of the scalp, tenderness, dermatitis (e.g., irritant), urticaria, edema, acne, alopecia, headache.

Drug Interactions

Specific Drugs and Laboratory Tests

Clobetasol Pharmacokinetics

Absorption

Bioavailability

Topically applied clobetasol propionate can be absorbed through normal intact skin.

Percutaneous penetration of clobetasol propionate varies among individuals and can be altered by using different vehicles.

Percutaneous penetration can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).

Distribution

Extent

Not known whether topical clobetasol is distributed into milk.

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.

Stability

Storage

Topical

Cream or Ointment

15–30°C; the cream should not be refrigerated.

Gel

2–30°C.

Solution

4–25°C; the solution should not be used near an open flame.

Foam

20–25°C; exposure to temperatures >49°C should be avoided. The container should not be punctured, used or stored near heat or an open flame, or placed into a fire or incinerator for disposal.

Keep out of reach of children.

Lotion

20–25°; freezing should be avoided.

Shampoo

Tight containers at 20–25°.

Actions

• High-range corticosteroid activity.

• Produces anti-inflammatory, antipruritic, and vasoconstrictor actions, possibly resulting in part from steroid receptor binding.

• Precise mechanism of action for topical anti-inflammatory activity is unknown; therapeutic benefit in the management of corticosteroid-responsive dermatoses mediated primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions.

• Anti-inflammatory effects may occur through induction of phospholipase A₂ inhibitory proteins (lipocortins); decreased arachidonic acid release from membrane phospholipids. Decreased arachidonic acid precursors may downregulate biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes).

Advice to Patients

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed. (See Topical Administration under Dosage and Administration.)

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.

• Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.

• Importance of patients informing clinician that they are receiving topical clobetasol propionate therapy, if surgery is contemplated.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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