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Desonate was approved by the FDA following two major clinical trials in 2006. Each randomized, double-blind, placebo-controlled study enrolled 582 pediatric patients (between the ages of 3 months and 18 years). [9] The patient was topically administered the drug or placebo two times a day for four weeks. Using the Investigator’s Global Severity Score (IGSS), the treatment was considered successful if at Week 4 there was at least a two (2) point decrease from the patient’s baseline IGSS. In clinical trial 1, 44% of patients succeeded successful treatment of Desonate versus 14% treated with the placebo. In clinical trial 2, 28% of patients succeeded successful treatment of Desonate versus 6% treated with the placebo.

Children and adolescents <16 years taking high doses of fluticasone propionate (typically ≥1000 micrograms/day) may be at particular risk of systemic effects. Systemic effects may occur, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in children and adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Consideration should be given to referring the child or adolescent to a paediatric respiratory specialist.

Mean peak plasma clobetasol propionate concentrations of ng/ml occurred in one study eight hours after the second application (13 hours after an initial application) of 30 g clobetasol propionate % ointment to normal individuals with healthy skin. Following the application of a second dose of 30 g clobetasol propionate cream % mean peak plasma concentrations were slightly higher than the ointment and occurred 10 hours after application. In a separate study, mean peak plasma concentrations of approximately ng/ml and ng/ml occurred respectively in patients with psoriasis and eczema three hours after a single application of 25 g clobetasol propionate % ointment.

Glucocorticosteroid medicine

glucocorticosteroid medicine

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