xerosis
Clobetasol (Temovate) Adverse Reactions
When used for recommended treatment periods of 14 days or less, clobetasol topical preparations are usually well tolerated. The most frequently reported adverse reactions to clobetasol therapy are local in nature and include burning sensations, pruritus and skin irritation. Burning and stinging sensations are more common with gel, emollient cream, and topical scalp foam/solution preparations of clobetasol and occur in 2 - 10% of patients. Other local adverse reactions reported in less than 2% of patients treated with clobetasol include acneiform rash, transient erythema, folliculitis, miliaria, perioral dermatitis, secondary infection, skin atrophy, skin hypopigmentation, skin peeling or cracking, xerosis, hypertrichosis, telangiectasia, and striae. Additional adverse reactions related to scalp application of clobetasol include alopecia, vesicular rash, ocular irritation, and headache in roughly 0.3% of patients. Adverse dermatologic effects are more likely to occur in intertriginous and facial areas, and tend to be more severe with fluorinated topical corticosteroids like clobetasol. Adverse dermatologic side effects of clobetasol are also more frequent with concurrent use of occlusive dressings. Some dermatologic effects, such as skin atrophy and striae, occur even with intermittent applications of high-potency topical corticosteroids, and may be permanent with prolonged treatment. Topical clobetasol preparations generally have a low degree of skin sensitization, but on rare occasions may cause an allergic contact dermatitis.
Topical clobetasol is systemically absorbed and can cause systemic adverse reactions, especially if applied to a large surface area or if occlusive dressings are used. Systemic absorption of topical corticosteroids such as clobetasol can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after withdrawal of treatment. In some patients, systemic absorption can produce manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria. HPA axis 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, and absence of response to ACTH stimulation. Clinical signs of increased intracranial pressure include bulging fontanelles, headaches, and bilateral papilledema. Clobetasol is a very-high-potency corticosteroid, and the risk of HPA axis suppression is greater than with other topical corticosteroids. However, the risk appears to be dose related. It is estimated that after 1 week of use of clobetasol at a dose of 3.5 grams twice daily (i.e., a 50-gram tube of clobetasol per week) over a 30% body surface area, 75% of adult patients will experience some degree of HPA axis suppression. In contrast, only 10% of adult patients using the equivalent of one 15-gram tube of clobetasol per week will have HPA axis suppression. One 4-week study of clobetasol emollient cream used in doses of 0.4 - 0.5 g twice daily in adult patients with plaque-type psoriasis resulted in no significant effects on serum cortisol concentrations or tolerability. Recovery of HPA axis function is rapid when clobetasol treatment is discontinued. Prescribers are advised to follow amount and duration guidelines for the use of clobetasol to minimize systemic effects. (see Contraindications/Precautions).
In general, excessive use of corticosteroids can lead to impaired wound healing. Since clobetasol is a topical corticosteroid, it should not be applied directly on or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection.
Case reports describe the development of extensive visual impairment in patients secondary to the onset of glaucoma or ocular hypertension during the use of potent topical corticosteroids to treat severe atopic eczema of the face. Cataracts have also been reported, usually with large doses or therapy > 6 months. Such adverse effects, if they occur, could lead to blindness. Clobetasol is generally not recommended for application to the face. Any patient who develops changes in vision while applying clobetasol to the scalp or other areas should be evaluated for ocular hypertension.
When prolonged treatment (2 months or more) of topical clobetasol therapy is abruptly discontinued, a dermatologic withdrawal syndrome can occur. This syndrome can include exfoliative dermatitis, or pustular reactions. Facial, perianal, or genital areas may be more susceptible to this effect. Improvement in these conditions would be expected to occur within a few weeks, but some patients may require systemic antibiotic or topical non-fluorinated anti-inflammatory treatment. Upon discontinuation of topical corticosteroid treatment, some patients with psoriasis or other severe, chronic inflammatory dermatoses may have exacerbation or rebound of the symptoms their condition.
Tolerance may occur with the prolonged use of topical corticosteroids. 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 (e.g., clobetasol is given twice daily for 2 - 3 weeks, followed by a 1-week intermission).
[ Last revised: 1/19/2004 12:42:00 PM ]
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