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Clobetasone foam: A review of open-label and controlled trials in adult and pediatric dermatoses

The safety and efficacy of clobetasol propionate emulsion foam 0.05% was determined in two phase II open-label and two phase III randomized, controlled studies. The open-label studies comprised a total of 84 subjects with mild to severe atopic dermatitis (AD) patients aged 6 years and over, or mild to moderate plaque psoriasis patients aged 12 years and over. These studies evaluated the effects of clobetasol foam on the hypothalamic pituitary adrenal axis (HPA). The phase III studies comprised a total of 874 patients with moderate to severe AD or mild to moderate plaque psoriasis. The composite primary endpoint for the AD study was an Investigator's Static Global Assessment (ISGA) score of ...