Vasoconstrictor assay for corticosteroids

The safety and efficacy of DIPROLENE Ointment for the treatment of corticosteroid-responsive dermatoses, psoriasis and atopic dermatitis, have been evaluated in three randomized active-controlled trials, two in psoriasis and one in atopic dermatitis . A total of 378 subjects, of whom 152 received DIPROLENE Ointment, were included in these trials. These trials evaluated DIPROLENE Ointment applied twice daily, for 14 days. DIPROLENE Ointment was shown to be effective in relieving signs and symptoms of psoriasis and atopic dermatitis.

Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with Lotrisone cream. In open-label trials, 17 of 43 (%) evaluable pediatric subjects (aged 12-16 years old) using Lotrisone cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label trial, 8 of 17 (%) evaluable pediatric subjects (aged 12-16 years old) using Lotrisone cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing.

In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, DIPROLENE AF Cream % was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of DIPROLENE AF Cream, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

Vasoconstrictor assay for corticosteroids

vasoconstrictor assay for corticosteroids

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