A comparison of the safety, tolerability, and efficacy of fluticasone propionate ointment, 0.005%, and betamethasone-17,21-dipropionate ointment, 0.05%, in the treatment of eczema.
A randomized, double-blind, parallel group study involving thirteen centers compared the safety, tolerability, and efficacy of twice-daily applications of fluticasone propionate ointment, 0.005%, and betamethasone-17, 21-dipropionate ointment, 0.05%, in ninety-two patients with moderate-to-severe eczema. Safety assessments included routine clinical laboratory evaluations, morning plasma cortisol levels, and reporting of adverse events. Efficacy assessments included (1) physician's gross assessment of clinical response of the target lesion, (2) severity of signs and symptoms of eczema, and (3) patients' assessment of treatment effects. Both treatments were well tolerated and showed minimal suppression of the hypothalamic-pituitary-adrenal axis as evidenced by morning plasma cortisol concentration determinations. Statistically significant improvement in the severity of each sign/symptom was found as early as two weeks following treatment initiation in both groups. The two treatments were found to be similar following two and four weeks of therapy with regard to almost all efficacy variables.