VA Class:DE200

ATC Class:D07AD01

AHFS Class:

• Corticosteroids 84:06.08

Generic Name(s):

• Clobetasol Propionate

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

Clobetasol propionate is a synthetic fluorinated corticosteroid.1

Clobetasol propionate shares the actions of other topical corticosteroids and is used for the short-term relief of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, including plaque psoriasis and dermatoses of the scalp (e.g., scalp psoriasis).1,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,32,74,78,81,82,83,84,85,86,88,89,90,91

Topical clobetasol propionate cream, ointment, gel, lotion, and foam are applied sparingly in thin films and are rubbed gently into the affected area twice daily, preferably in the morning and evening.1,87,88,89,90 Clobetasol propionate solution is applied to affected areas of the scalp twice daily, in the morning and evening.80,81,84 Clobetasol propionate shampoo is applied in a thin film to affected areas of the dry (not wet) scalp once daily; the shampoo should be left in place for 15 minutes before lathering and rinsing.91 Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids,80,91 clobetasol propionate cream, ointment, gel, lotion, foam, and shampoo should not be applied to the face or intertriginous areas (e.g., axilla, groin).1,87,88,89,90,91 Although there are no restrictions regarding use of clobetasol propionate solution on the face, axilla, or groin, the manufacturer states that patients receiving the solution should be observed frequently if these areas are to be treated.80

When clobetasol propionate foam is applied, the canister containing the drug should be inverted and a small amount (up to a maximum of a golf-ball-sized dollop or 1½ capfuls) of the preparation placed into the cap of the canister, onto a saucer, or other cool surface, or directly on the lesion, taking care to avoid contact with the eyes.88 The foam should not be dispensed directly to the hands (unless the hands are the affected area), since the foam will begin to melt immediately upon contact with warm skin.88 If the canister seems warm to the touch or the foam seems runny, the canister should be placed under cold running tap water.88 When applying clobetasol propionate foam to a hairy area, hair should be moved away from the affected area to allow application of the drug onto each affected area.88 The drug should be massaged gently with clean, dry fingertips into the affected area until the foam disappears; repeat until the entire affected area has been treated.88 Clobetasol propionate foam is flammable; therefore, exposure to flames or smoking should be avoided during and immediately after application.88

When clobetasol propionate shampoo is applied to the dry scalp, hair should be moved away from the affected area to allow application of the drug directly onto each affected area.91 The bottle should be positioned over the affected area and gently squeezed so that a small amount of shampoo is released directly onto the affected area, avoiding any contact with the face, eyes, or lips; if accidental contact occurs, the area should be rinsed thoroughly with water.91 After application onto the scalp, the drug should be spread so that the entire affected area is covered with a thin uniform film.91 The drug should then be massaged gently into the affected area; the procedure should be repeated to treat additional affected areas.91 When all affected areas have been treated, the hands should be washed, and the shampoo should be left in place for 15 minutes.91 After 15 minutes, water should be added and the shampoo should be lathered, and then all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck, shoulders) should be rinsed thoroughly.91 Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used if desired.91

Some patients may respond initially to once-daily66 or intermittent therapy (e.g., twice daily 3 days per week).29 Clobetasol therapy should be discontinued and a less potent topical corticosteroid preparation substituted as soon as clinically feasible,77 but dosage should not exceed 50 g of clobetasol propionate 0.05% cream, foam, or ointment or 50 mL (50 g) of clobetasol propionate 0.05% lotion, solution, or shampoo per week.1,77,80,88,89,90,91 Use of clobetasol propionate cream, foam, gel, lotion, ointment, or solution generally should not exceed 14 days.1,77,80,88,89,90 Although clobetasol propionate 0.05% 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, the manufacturers state that additional benefits of extended treatment (i.e., beyond 2 weeks) should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA)-axis suppression.89,90 The manufacturer states that use of clobetasol propionate 0.05% shampoo should be limited to 4 consecutive weeks.91 If complete resolution is not achieved following 4 weeks of therapy, a less potent topical corticosteroid may be substituted for clobetasol propionate shampoo.91 If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.91

Many clinicians indicate that more prolonged clobetasol therapy rarely may be necessary in patients with resistant conditions,3,5,6,9,10,12,13,14,16,20,21,23,24,27,29,32,74,75,77 but careful monitoring is essential.75,77 The risk of adverse systemic corticosteroid effects (e.g., HPA-axis suppression, Cushing's syndrome, hyperglycemia) associated with use of this potent corticosteroid must be carefully considered.1,88 Intermittent maintenance therapy, such as administration of the drug once-12 or twice-weekly20,21 for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.12,20,21

Clobetasol propionate cream, foam, gel, lotion, ointment, solution, or shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive.1,80,87,88,89,90,91

Clobetasol propionate shares the toxic potentials of other topical corticosteroids,1,3,7,11,12,13,14,17,19,20,21,22,26,27,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,78,79 and the usual precautions of corticosteroid therapy should be observed.1,3,46 (See Cautions in the Topical Corticosteroids General Statement 84:06.)

Clobetasol propionate preparations are some of the most potent topical corticosteroid preparations currently available.33,34,35,36,37,38,39,40,41,42,43,44,45,88 Because of its potency, the drug can suppress the hypothalamic-pituitary-adrenal (HPA) axis following topical application,3,7,11,12,13,17,18,19,20,26,27,46,55,57,59,61,62,64,88,90,91 and 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 .1,76,88 Some data indicate that clobetasol propionate 0.05% lotion may be associated with a higher incidence of HPA axis suppression than clobetasol propionate 0.05% emollient cream.90 Because of the drug's potency and potential for causing adverse systemic effects during topical therapy, the usual dosage should not be exceeded, and occlusive dressings (including bandages) should not be applied to areas of clobetasol propionate application.1,80,87,88,89,90,91 (See Dosage and Administration.)

Burning and/or stinging sensation, pustules on the scalp, tingling, folliculitis, itching, tightening of the scalp, tenderness, dermatitis, alopecia, and headache may occur in some patients receiving clobetasol propionate solution applied to the scalp.80 Eye irritation also may occur if clobetasol propionate solution comes in contact with the eye(s); if such contact occurs, the affected eye(s) should be flushed with copious amounts of water.80,81,82,83

If irritation occurs during treatment, clobetasol propionate cream, ointment, gel, foam, lotion, solution, or shampoo should be discontinued and appropriate therapy instituted.1,80,87,88,89,90,91

Clobetasol should not be used in the treatment of rosacea1,6,18,80,87,89,90 or perioral dermatitis.1,80,87,89,90 Topical corticosteroids generally should not be used in the treatment of acne6,18,80 or as monotherapy in the treatment of widespread plaque psoriasis.80

If concomitant skin infections develop during clobetasol therapy, appropriate antifungal or antibacterial therapy should be initiated; if the infection does not respond promptly to such therapy, clobetasol should be discontinued until the infection has been controlled adequately.1,80,87,88,89,90,91

When surgery is required, patients should be advised to inform the attending clinician, dentist, or anesthesiologist that they are receiving clobetasol propionate therapy.87,89,90,91

The manufacturers state that clobetasol propionate preparations are contraindicated in individuals with known hypersensitivity to the drug, other corticosteroids, or any ingredient in the respective formulation.1,80,87,88,89,90,91 Clobetasol propionate solution also is contraindicated in individuals with primary infections of the scalp.80

Pediatric Precautions

Safety and efficacy of clobetasol propionate have not been established in pediatric patients.1,87,89,90 Therefore, use of clobetasol propionate cream, ointment, foam, gel, or solution in children younger than 12 years of age is not recommended.1,80,87,88,89 Use of clobetasol propionate lotion or shampoo is not recommended in patients younger than 18 years of age.90,91 Use of clobetasol propionate emollient cream beyond 2 consecutive weeks has not been evaluated in pediatric patients younger than 16 years of age.89 (See Cautions: Pediatric Precautions, in the Topical Corticosteroids General Statement 84:06.)

Geriatric Precautions

Clinical studies of clobetasol propionate preparations did not include sufficient numbers of patients 65 years of age and older to warrant systematic evaluation of efficacy and safety of the drug in this patient population.1,80,87,88,89,90,91 However, adverse effects reported in geriatric patients generally were similar to those observed in younger patients.1,80,88,89 While no dosage adjustment is necessary in geriatric patients receiving clobetasol propionate cream,1,89 ointment,1 gel,87 or solution,80 the manufacturers of clobetasol propionate foam, lotion, or shampoo state that dosage should be titrated carefully in these patients, usually initiating therapy at the low end of the dosage range, since decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy are more common in this age group than in younger patients.88,90,91

Mutagenicity and Carcinogenicity

No evidence of clobetasol-induced mutagenesis was seen in various in vitro microbial test systems (e.g., Ames test) with or without metabolic activation.1,76,80,87,88,89,90,91 Long-term studies to determine the carcinogenic potential of topical corticosteroids have not been performed to date.1,80,87,88,89,90,91

Pregnancy, Fertility, and Lactation

Pregnancy

The teratogenic potential of topical clobetasol propionate is not known; however, the drug appears to undergo percutaneous absorption, and reproduction studies in mice and rabbits using subcutaneous dosages of the drug as low as 30 mcg/kg (approximately 0.04 times the human topical dose) or 3 mcg/kg (approximately 0.02 times the human topical dose), respectively, have revealed evidence of substantial harm to the fetus (e.g., cleft palate, cranioschisis, skeletal abnormalities).1,80,87,88,89,90 Teratogenic effects of clobetasol were observed at subcutaneous dosages about one-fourth to one-twelfth those of betamethasone in these animals.76 In addition, although the teratogenic potential of topical clobetasol has not been studied, other potent corticosteroids have been shown to be teratogenic in animals following topical application.1,80,87,88,89,90,91

Fertility

Reproduction studies in rats using subcutaneous dosages of clobetasol propionate up to 50 mcg/kg daily have revealed an increase in the incidence of fetal resorption and a decrease in the number of living fetuses at the highest dose.1,80,87,88,89,90

For additional information, see Cautions: Pregnancy, Fertility, and Lactation, in the Topical Corticosteroids General Statement 84:06.

Pharmacokinetics

Absorption

Percutaneous penetration of clobetasol propionate varies among individuals5,33,34,35,41,42,61,66,67,69,70 and can be altered by using different vehicles;1,7,18,22,30,31,41,43,67,69,71,73,80,87,88,89,90,91 results of in vitro studies using human skin indicate that absorption of topically applied clobetasol propionate gel is greater than that of topically applied clobetasol propionate cream.87 Percutaneous penetration can be increased by the use of occlusive dressings1,7,8,18,22,62,69,70,72,80,87,88,89,90,91 and by inflammation and/or other diseases of the epidermal barrier (e.g., psoriasis, eczema).1,18,62,66,70,71,72,73,80,87,88,89,90,91

Following topical application of clobetasol propionate to most areas of normal skin, only small amounts of the drug appear to reach the dermis66 and subsequently the systemic circulation with the usual dosa 61,66,67 however, systemic absorption may be increased when the usual dosage is exceeded3,7,11,13,46,59,61,64,79 or when the skin is inflamed or diseased.1,18,59,62,66,70,72,73 Mean peak plasma clobetasol propionate concentrations of 0.63 ng/mL occurred in one study 8 hours after a second 30-g dose (applied 13 hours after an initial dose) of clobetasol propionate 0.05% ointment in healthy individuals with normal skin; mean peak plasma concentrations of the drug were slightly higher and occurred 10 hours after the second dose when the 0.05% cream was employed.67 Mean peak plasma concentrations of approximately 2.3 or 4.6 ng/mL occurred in another study about 3 hours after a single application of a 25-g dose of a 0.05% ointment in patients with psoriasis or eczema, respectively.66

Elimination

Following percutaneous penetration of clobetasol propionate, drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids.76,80,88,90 (See Pharmacokinetics: Elimination, in the Corticosteroids General Statement 68:04.) However, systemic metabolism of clobetasol has not been fully characterized or quantified.76 Clobetasol and its metabolites are excreted in bile1,76 and in urine76 in animals.

Chemistry and Stability

Chemistry

Clobetasol propionate is a synthetic fluorinated corticosteroid.1,80,87,88,89,90,91 The drug occurs as a white to cream-colored, crystalline powder,1,2,80,87,88,89,90,91 is odorless,2,88 and has solubilities of 2 mcg/mL in water at room temperature2 and 10 mg/mL in alcohol.2

Stability

Clobetasol propionate cream or ointment should be stored at 15-30°C; the cream should not be refrigerated.1,89 Clobetasol propionate gel should be stored at 2-30°C.87 Clobetasol propionate solution should be stored at 4-25°C; the solution should not be used near an open flame.80 Clobetasol propionate lotion or shampoo should be stored at 20-25°C;90,91 clobetasol propionate lotion should be protected from freezing.90 Clobetasol propionate foam should be stored at a controlled room temperature between 20-25°C, and exposure to temperatures warmer than 49°C should be avoided.88 Because the contents of the foam are under pressure, the container should not be punctured, used or stored near heat or an open flame, or placed into a fire or incinerator for disposal.88

Additional Information

For further information on chemistry, pharmacology, absorption, uses, cautions, and methods of application of clobetasol propionate, see the Topical Corticosteroids General Statement 84:06.

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