Spinosad topical suspension (0.9%): a new topical treatment for scabies

References

• WHO. World Health Organisation [ updated 2020 Aug 16; cited 2022 Apr 05]. Available from: https://www.who.int/news-room/fact-sheets/detail/scabies
   Google Scholar
• Report of the Tenth Meeting of the WHO Strategic and Technical Advisory Group for Neglected Tropical Diseases 2017 Mar 29–30 WHO, Geneva. Available from: http://www.who.int/neglected_diseases/events/tenth_stag/en/03/2017
   Google Scholar
• Romani L, Steer AC, Whitfeld MJ, et al. Prevalence of scabies and impetigo worldwide: a systematic review. Lancet Infect Dis. 2015;15(8):960–967.
   PubMed Web of Science ®Google Scholar
• Mounsey KE, Murray HC, King M, et al. Retrospective analysis of institutional scabies outbreaks from 1984 to 2013: lessons learned and moving forward. Epidemiol Infect. 2016;144(11):2462–2471.
   PubMed Web of Science ®Google Scholar
• Chosidow O. Scabies. N Engl J Med. 2006;354(16):1718–1727.
   PubMed Web of Science ®Google Scholar
• Bernigaud C, Samarawickrama GR, Jones MK, et al., The challenge of developing a single-dose treatment for Scabies. Trends Parasitol. 35(11): 931–943. 2019.
   PubMed Web of Science ®Google Scholar
• Chandler DJ, Fuller LC. A review of Scabies: an infestation more than skin deep. Dermatol. 2019;235(2):79–90.
   PubMed Web of Science ®Google Scholar
• Bergström FC, Reynolds S, Johnstone M, et al. Scabies mite inactivated serine protease paralogs inhibit the human complement system. Immunol Res. 2009;182(12):7809.
   Google Scholar
• Beckham SA, Boyd SE, Reynolds S, et al. Characterization of a serine protease homologous to house dust mite group 3 allergens from the scabies mite Sarcoptes scabiei. J Biol Chem. 2009 Dec 4;284(49):34413–34422.
   PubMed Web of Science ®Google Scholar
• Engelman D, Yoshizumi J, Hay RJ, et al. The 2020 international alliance for the control of scabies consensus criteria for the diagnosis of scabies. Br J Dermatol. 2020 Nov;183(5):808–820.
   PubMed Web of Science ®Google Scholar
• Bernigaud C, Fernando DD, Lu H, et al. How to eliminate scabies parasites from fomites: a high-throughput ex-vivo experimental study. J Am Acad Dermatol. 2020;83(1):241–245.
   PubMed Web of Science ®Google Scholar
• Thadanipon K, Anothaisintawee T, and Rattanasiri S, et al., Efficacy and safety of antiscabietic agents: a systematic review and network meta-analysis of randomized controlled trials. J Am Acad Dermatol. 80(5): 1435–1444. 2019.
   PubMed Web of Science ®Google Scholar
• Salavastru CM, Chosidow O, Boffa MJ, et al. European guideline for the management of scabies. J Eur Acad Dermatol Venereol. 2017;31(8):1248–1253.
   PubMed Web of Science ®Google Scholar
• CDC. Centers for Disease Control and Prevention. [ updated 2019 Oct 2; cited 2022 Apr 06]. Available from: https://www.cdc.gov/parasites/scabies/health_professionals/meds.html
   Google Scholar
• Sashidharan P, Basavaraj S, Bates C. UK national guideline on the management of scabies. Macclesfield (GB): British Association for Sexual Health and HIV; 2016.
   Google Scholar
• Myra Hardy DE, Steer A. Scabies: a clinical update. Aust J Gen Pract. 2017;46:264–268.
   Google Scholar
• OMA M. AusPAR: Ivermectin. 2013. Available from: https://www.tga.gov.au/sites/default/files/auspar-ivermectin-131030-pi.pdf
   Google Scholar
• Diagnosis ECoGft, Scabies To. Guideline for the diagnosis and treatment of scabies in Japan (third edition). J Dermatol. 2017;44(9):991–1014.
   PubMed Web of Science ®Google Scholar
• Salgado VL. Studies on the mode of action of spinosad: insect symptoms and physiological correlates. Pestic Biochem Physiol. 1998;60(2):91–102.
   Web of Science ®Google Scholar
• Pasay C, Arlian L, Morgan M, et al. High-resolution melt analysis for the detection of a mutation associated with permethrin resistance in a population of scabies mites. Med Vet Entomol. 2008;22(1):82–88.
   PubMed Web of Science ®Google Scholar
• Mounsey KE, Dent JA, Holt DC, et al. Molecular characterisation of a pH-gated chloride channel from Sarcoptes scabiei. Invert Neurosci. 2007;7(3):149–156.
   PubMedGoogle Scholar
• Tomalik-Scharte D, Lazar A, Meins J, et al. Dermal absorption of permethrin following topical administration. Eur J Clin Pharmacol. 2005;61(5–6):399–404.
   PubMed Web of Science ®Google Scholar
• Strong M, Johnstone P. Cochrane review: interventions for treating scabies. Evidence Based Child Health Cochrane Rev J. 2011;6(6):1790–1862.
   Google Scholar
• Shaikh J. Benzyl benzoate. In: Wexler P, editor. Encyclopedia of toxicology. 2nd ed. Vol. 1. USA: Academic Press; 2005. p. 264–265.
   Google Scholar
• Nolan K, Kamrath J, Levitt J. Lindane toxicity: a comprehensive review of the medical literature. Pediatr Dermatol. 2012;29(2):141–146.
   PubMed Web of Science ®Google Scholar
• Currie BJ, McCarthy JS. Permethrin and ivermectin for scabies. N Engl J Med. 2010;362(8):717–725.
   PubMed Web of Science ®Google Scholar
• Huffam SE, Currie BJ. Ivermectin for Sarcoptes scabiei hyperinfestation. Int J Infect Dis. 1998;2(3):152–154.
   PubMedGoogle Scholar
• Romani L, Whitfeld MJ, Koroivueta J, et al. Mass drug administration for scabies control in a population with endemic disease. N Engl J Med. 2015;373(24):2305–2313.
   PubMed Web of Science ®Google Scholar
• Bernigaud C, Fernando DD, Lu H, et al. In vitro ovicidal activity of current and under-development scabicides: which treatments kill scabies eggs? Br J Dermatol. 2020;182(2):511–513.
   PubMed Web of Science ®Google Scholar
• Bernigaud C, Fang F, Fischer K, et al. Preclinical study of single-dose moxidectin, a new oral treatment for scabies: efficacy, safety, and pharmacokinetics compared to two-dose ivermectin in a porcine model. PLoS Negl Trop Dis. 2016;10(10):e0005030.
   PubMed Web of Science ®Google Scholar
• Levy M, Martin L, Bursztejn AC, et al. Ivermectin safety in infants and children under 15 kg treated for scabies: a multicentric observational study. Br J Dermatol. 2020;182(4):1003–1006.
   PubMed Web of Science ®Google Scholar
• Jittamala P, Monteiro W, Smit MR, et al. A systematic review and an individual patient data meta-analysis of ivermectin use in children weighing less than fifteen kilograms: is it time to reconsider the current contraindication? PLoS Negl Trop Dis. 2021;15(3):e0009144.
   PubMed Web of Science ®Google Scholar
• Mounsey KE, McCarthy JS. Treatment and control of scabies. Curr Opin Infect Dis. 2013;26(2):133–139.
   PubMed Web of Science ®Google Scholar
• Khalil S, Abbas O, Kibbi AG, et al. Scabies in the age of increasing drug resistance. PLoS Negl Trop Dis. 2017;11(11):e0005920.
   PubMed Web of Science ®Google Scholar
• Flinders DC, De Schweinitz P. Pediculosis and scabies. Am Fam Physician. 2004;69(2):341–348.
   PubMed Web of Science ®Google Scholar
• Balestri R, Magnano M, Infusino SD, et al. Scabies is becoming less sensitive to permethrin therapy. J Eur Acad Dermatol Venereol. 2021;35(12):e889–e891.
   PubMed Web of Science ®Google Scholar
• Fraser J. Permethrin: a top end viewpoint and experience. Med J Aust. 1994;160(12):806.
   PubMed Web of Science ®Google Scholar
• Mounsey KE, Bernigaud C, Chosidow O, et al. Prospects for moxidectin as a new oral treatment for human scabies. PLoS Negl Trop Dis. 2016;10(3):e0004389.
   PubMed Web of Science ®Google Scholar
• Cada DJ, Levien TL, Baker DE. Spinosad 0.9% topical suspension. Hosp Pharm. 2011;46(6):436–440.
   Google Scholar
• Agency UEP, editor. Pesticide fact sheet: spinosad. Washington (DC): US Environmental Protection Agency, Office of Pesticide Programs; 1997.
   Google Scholar
• Seiler JC, Keech RC, and Aker JL, et al., Spinosad at 0.9% in the treatment of scabies: efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies. J Am Acad Dermatol. 2022;86(1):97–103.
   PubMed Web of Science ®Google Scholar
• Cueto GM, Zerba E, and Picollo MI. Embryonic development of human lice: rearing conditions and susceptibility to spinosad. Mem Inst Oswaldo Cruz. 2006;101(3):257–261.
   PubMed Web of Science ®Google Scholar
• Degtyarenko K, de Matos P, Ennis M, et al. ChEBI: a database and ontology for chemical entities of biological interest. Nucleic Acids Res. 1994;36:D344–D350.
   Google Scholar
• McCormack PL. Spinosad. Am J Clin Dermatol. 2011;12(5):349–353.
   PubMed Web of Science ®Google Scholar
• FDA. Prescribing information for NATROBA topical suspension. USA: States Food and Drug Administration. 2021.
   Google Scholar
• FDA. Pediatric postmarketing pharmacovigilance review: natroba (spinosad topical suspension 0.9%). Center for Drug Evaluation and Research Office of Surveillance and Epidemiology, US Food and Drug Administration.
   Google Scholar
• ParaPRO LCR. A Phase 3, randomized, double blind, placebo-controlled study to assess the safety, efficacy and pharmacokinetics of spinosad topical suspension 0.9% for the treatment of scabies. Clinical Study Protocol. 2018;60:1–66.
   Google Scholar
• Davis JS, McGloughlin S, Tong SYC, et al. A novel clinical grading scale to guide the management of crusted scabies. PLoS Negl Trop Dis. 2013;7(9):e2387.
   PubMed Web of Science ®Google Scholar