Efficacy and safety of fluticasone propionate ointment, 0.005%, in the treatment of eczema

The clinical efficacy and safety of fluticasone propionate ointment, 0.005%, were compared with those of its vehicle in the treatment of moderate-to-severe eczema of long duration in two multicenter, double-blind, vehicle-controlled, randomized studies. One of the two study medications (up to 100 gm/week) was applied topically to the affected areas of the body twice daily for up to four consecutive weeks. Drug efficacy was measured in terms of three variables: the physician's gross assessment of clinical response of the target lesion, severity scores of individual signs and symptoms, and the patient's subjective assessment of treatment effects. Efficacy and safety were evaluated after seven, fourteen, twenty-one, and twenty-eight days of treatment. The total number of patients in the two studies was 372 (203 in study 1 and 169 in study 2). Fluticasone propionate ointment, 0.005%, was more effective than vehicle at all postbaseline visits in both studies (study 1 P ≤ 0.015, study 2 P ≤ 0.018). In study 1, approximately 80% of the patients on fluticasone were rated as cleared, excellent, or good by the investigators at treatment endpoint, compared with 38% of those receiving vehicle. In study 2, the sum of 80% of the fluticasone-treated patients was rated as cleared, excellent, or good by the investigators at the end of the study, compared with 34% of those receiving vehicle. The beneficial effect of fluticasone ointment, 0.005%, was early and sustained and was particularly noticeable for pruritus, erythema, and skin thickening. In study 1, no drug-related adverse events were reported in the fluticasone group. Four patients (4.3%) in the vehicle group experienced a total of four drug-related adverse events. The most common was burning/stinging, reported by two patients. In study 2, two patients (2.4%) in the fluticasone-treated group and three (4.1%) in the vehicle group reported a total of five drug-related adverse events, the most common event being pruritus (fluticasone group one patient, vehicle group two patients). These findings show that fluticasone propionate ointment, 0.005%, applied twice daily, is therapeutically superior to the vehicle and is well tolerated.