Double-blind, comparative clinical trials with halobetasol propionate cream in patients with atopic dermatitis.

In two double-blind, parallel-group, multicenter trials, 0.05% halobetasol propionate cream was compared with 0.05% clobetasol 17-propionate cream and 0.05% betamethasone dipropionate cream in 264 patients with acute, severe exacerbations of atopic dermatitis. The efficacy of halobetasol propionate cream and betamethasone dipropionate cream was similar with regard to the success rate, as indicated by ratings of "healed" and "marked improvement" (88% versus 90%) and by an onset of therapeutic effect within 3 days of the start of treatment (40% versus 39%). The efficacy of halobetasol propionate cream and clobetasol 17-propionate cream was also similar with regard to success rates (89% versus 93%) and an onset of therapeutic effect within 3 days of the start of treatment (41% versus 38%). All three creams were well tolerated. Dryness of the skin and itching at the site of application were the reported adverse effects. Treatment was discontinued because of severe dryness of the skin in 1 of the 121 patients treated with halobetasol propionate cream and in 1 of the 59 patients treated with betamethasone dipropionate cream.

[Comparative clinical trial of a new trihalogenated dermatocorticoid (halometasone) versus betamethasone dipropionate]. / Klinische Vergleichsprüfung zwischen einem neuen trihalogenierten Dermatokortikoid (Halometason) und Betamethasondipropionat.

In a multicenter controlled study carried out in Austria and Switzerland by 8 dermatologists in 208 patients with acute eczematous dermatoses, 0.05% halometasone cream proved to have significantly superior clinical efficacy than 0.05% betamethasone dipropionate cream (P much less than 0.05) showing an equal tolerability. Good to very good results were reported in 93% of the patients treated with halometasone and in 84% of those treated with betamethasone dipropionate creams (Diprosone, Diproderm). General tolerability of both treatments was good. Neither skin atrophy nor any systemic adverse effect, due to the transcutaneous absorption of the corticoids, were observed in this study.

An overview of international clinical trials with halometasone cream.

In international multicentre comparative clinical trials carried out by dermatologists in 717 patients with non-infected acute eczematous dermatoses at 28 trial centres in Austria, Germany, Holland, Switzerland and Yugoslavia, halometasone cream exhibited a very satisfactory therapeutic effect in acute contact dermatitis, atopic dermatitis, nummular dermatitis and seborrhoeic dermatitis. It yielded 'good' to 'very good' results in 89.7% of the 333 patients treated with halometasone cream. Halometasone cream was significantly more effective than Diproderm, Diprosone and Ultralan creams with respect to the overall success rate, the percentage of patients with 'very good' results and early cures. It proved marginally superior to Halciderm cream in therapeutic efficacy. The onset of therapeutic effect was more rapid in patients treated with halometasone cream than in those on treatment with comparative preparations. Halometasone cream was well tolerated and neither skin atrophy nor any systemic effect due to the transcutaneous systemic absorption of the corticoid was observed. In view of the rapid onset of action, very good efficacy and tolerability, halometasone cream, with agreeable cosmetic and applicatory properties, may be considered as a suitable corticosteroid topical for the treatment of acute eczematous and other corticosteroid-responsive dermatoses.