Spinosad at 0.9% in the treatment of scabies: Efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies - 09/12/21
Abstract |
Background |
Scabies is a contagious skin disease resulting from Sarcoptes scabiei infestation. There are no approved over-the-counter treatments, and approved prescription products have disadvantages, including potential resistance. Spinosad, an insecticide derived from fermentation of a soil actinobacterium, shows promise as a potential treatment agent.
Objective |
Combined results from 2 controlled clinical studies were used to evaluate the efficacy of 0.9% spinosad topical suspension in the eradication of scabies.
Methods |
Each study included index subjects (the youngest household members with active scabies) and up to 5 other members in each household. Subjects applied 0.9% spinosad or vehicle once. Primary efficacy was the percentage of index subjects with complete cure on day 28. Additional efficacy included clinical cure, microscopic cure, and lesion counts.
Results |
Spinosad at 0.9% is not equivalent to vehicle in the percentage of index subjects achieving complete cure on day 28 (78.1% vs 39.6%, respectively; P < .0001; n = 206). Additional efficacy analyses confirmed the consistent treatment effect of 0.9% spinosad. No safety signals were observed.
Limitations |
The studies used small sample sizes to assess equivalency.
Conclusions |
Spinosad at 0.9% performed better than vehicle in the treatment of scabies in these studies of subjects of 4 years of age or older following 1 application of study drug.
Le texte complet de cet article est disponible en PDF.Key words : efficacy, Natroba, pediatric, scabies, spinosad, topical
Abbreviation used : AE
Plan
Funding sources: Sponsored and supported by ParaPRO LLC. |
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IRB approval status: The studies described herein were registered on ClinicalTrials.gov as NCT02485717 and NCT02485704 (both initially posted June 30, 2015). Advarra (formerly known as Schulman IRB), a central institutional review board, reviewed and approved the protocols and associated informed consent/assent forms. Concentrics Research was the contract research organization that planned and conducted the study. |
Vol 86 - N° 1
P. 97-103 - janvier 2022 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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