The Safety of Halobetasol 0.05% Ointment in the Treatment of Psoriasis

Abstract

The effects on the hypothalamic‐pituitary‐adrenal axis of the ultra‐high potency corticosteroid halobetasol in the treatment of psoriasis were evaluated in seven patients with extensive, long‐standing plaque psoriasis. Each patient applied 3.5 g halobetasol 0.05% ointment in the morning and evening for 7 days. Morning plasma Cortisol levels and 24‐hour urinary excretion of 17‐hydroxycorticosteroid were determined before and on the last 2 days of treatment; plasma Cortisol levels were also determined 4 and 5 days after completion of therapy. Morning plasma Cortisol concentrations did not decrease significantly during treatment, and no values were below the normal range. Mean 24‐hour urinary 17‐hydroxycorticosteroid excretion fell from 6.6 ± 1.4 mg to 5.1 ± 1.4 mg. Two patients had mild, localized pruritus and stinging with the initial ointment application. No other adverse cutaneous effects were observed. Halobetasol was also clinically efficacious over the 7 days of treatment, based on evaluation of pruritus, erythema, scaling, and plaque elevation. These results demonstrate no adverse effects of the drug on the hypothalamic‐pituitary‐adrenal axis at doses that are clinically effective in the management of plaque psoriasis.