Efficacy demonstrating the FDA’s new criteria for "complete cure" outcomes.1
Spinosad Topical Suspension 0.9% offers substantiated efficacy in treating adult and pediatric (4 years of age and older) scabies infestations.
See the efficacy dataResults from two Phase III, clinical studies based on a single, full-body application of Spinosad Topical Suspension 0.9%.1
When applied on the outer layer of the epidermis, the active compound (spinosad) is absorbed into the stratum corneum (but not beyond) before sloughing off through the natural process of non-pathologic desquamation (over approximately 14 days).1,2
In two phase III, multicenter, randomized, double-blind, vehicle-controlled studies, under patient-directed usage, evaluating a single application of Spinosad Topical Suspension 0.9% or vehicle in 206 patients, significantly more patients using Spinosad Topical Suspension 0.9% achieved a complete cure 28 days after treatment compared to vehicle, 69.8% vs. 46.5% (P-value=0.0271) and 83.9% vs. 34.5% (P-value<0.0001), respectively. Patients were less likely to develop new scabies lesions over the 28 days following treatment with Spinosad Topical Suspension 0.9% than following treatment with vehicle.
Reference(s)
- Spinosad Topical Suspension 0.9% Prescribing Information.
- Jackson SM, et. al: Pathobiology of the stratum corneum. West J Med 1993 Mar; 158:279-285).
SPN-SW5-000