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