Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals

Lidia Serrano, Lorraine S. Decesar, Loan Pham

Carmago Pharmaceutical Services, Cincinnati, USA..
South Florida Family Health and Research Centers, Plantation, USA.

DOI: 10.4236/pp.2013.42038                

Abstract

Head lice are a public health issue, and resistance to available over-the-counter pediculicides is a concern. The objective of this randomized study was to evaluate the pediculicidal activity and safety of 1% Sodium Chloride spray (0.1709 M), (LiceFreee Spray®) compared to the current recommended treatment for head lice with 1% Permethrin Crème Rinse. Forty-two subjects were randomized equally into Sodium Chloride or Permethrin group. Products were applied to hair according to the label instructions. After application of the products at Day 1 and Day 8, pediculicidal efficacy and safety were assessed at Day 1, Day 8 and Day 15. Second treatment was only applied on Day 8 to individuals with observed live lice using the same products and protocols as Day 1. Proportion of lice free subjects per group, the reduction in number of live lice per head and adverse effects were recorded after each visit. The results showed significantly higher pediculicidal activity for Sodium Chloride spray (85%) as compared to Permethrin (45%) at Day 15 (p < 0.05). Similar numbers of lice per head (21.76 range 10 to 68 versus 21.29 range 10 to 60 for Sodium Chloride and Permethrin groups, respectively) were observed for individuals at Day 1. At Day 15, lice per head infested reduced to 0.55 ± 1.50 in Sodium Chloride spray group compared to 5.45 ± 7.91 in the Permethrin group (p < 0.01). No serious adverse effects were observed in both groups. Sodium Chloride spray had superior efficacy to 1% Permethrin Crème Rinse in treating head lice and is a safe and excellent alternative to the current recommended treatment.

Keywords

Head Lice; Sodium Chloride; LiceFreee Spray®; Nix®; Permethrin

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	M. E. Falagas, D. K. Matthaiou, P. I. Rafailidis, G. Panos and G. Pappas, “Worldwide Prevalence of Head Lice,” Emerging Infectious Diseases, Vol. 14, No. 9, 2008, pp. 1493-1494. doi:10.3201/eid1409.080368
[2]	P. E. Fournier, J. B. Ndihokubwayo, J. Guidran, P. J. Kelly and D. Raoult, “Human Pathogens in Body and Head Lice,” Emerging Infectious Diseases, Vol. 8, No. 12, 2002, pp. 1515-1518. doi:10.3201/eid0812.020111
[3]	K. Y. Mumcuoglu, S. Klaus, D. Kafka, M. Teiler and J. Miller, “Clinical Observations Related to Head Lice Infestation,” Journal of the American Academy of Dermatology, Vol. 25, No. 2, 1991, pp. 248-251. doi:10.1016/0190-9622(91)70190-D
[4]	D. Taplin and T. L. Meinking, “Scabies, Lice, and Fungal Infections,” Primary Care, Vol. 16, No. 3, 1989, pp. 551576.
[5]	M. Tebruegge, A. Pantazidou and N. Curtis, “What’s Bugging You? An Update on the Treatment of Head Lice Infestation,” Archives of Disease in Childhood-Education and Practice, Vol. 96, No. 1, 2010, pp. 2-8. doi:10.1136/adc.2009.178038
[6]	K. Y. Mumcuoglu, T. A. Meinking, C. N. Burkhart and C. G. Burkhart, “Head Louse Infestations: The “No Nit” Policy and Its Consequences,” International Journal of Dermatolog, Vol. 45, No. 8, 2006, pp. 891-896. doi:10.1111/j.1365-4632.2006.02827.x
[7]	CDC, “Parasites-Lice-Head Lice Diagnosis,” 2011. http://www.cdc.gov/parasites/lice/head/diagnosis.html
[8]	C. N. Burkhart and C. G. Burkhart, “Fomite Transmission in Head Lice,” Journal of the American Academy of Dermatology, Vol. 56, No. 6, 2007, pp. 1044-1047. doi:10.1016/j.jaad.2006.10.979
[9]	M. Takano-Lee, J. D. Edman, B. A. Mullens and J. M. Clark, “Transmission Potential of the Human Head Louse, Pediculus capitis (Anoplura: Pediculidae),” International Journal of Dermatolog, Vol. 44, No. 10, 2005, pp. 811816. doi:10.1111/j.1365-4632.2005.02418.x
[10]	A. M. Downs, K. A. Stafford, L. P. Hunt, J. C. Ravenscroft and G. C. Coles, “Widespread Insecticide Resistance in Head Lice to the Over-the-Counter Pediculocides in England, and the Emergence of Carbaryl Resistance,” British Journal of Dermatology, Vol. 146, No. 1, 2002, pp. 88-93. doi:10.1046/j.1365-2133.2002.04473.x
[11]	T. L. Meinking, M. Vicaria, D. H. Eyerdam, M. E. Villar, S. Reyna and G. Suarez, “Efficacy of a Reduced Application Time of Ovide Lotion (0.5% Malathion) Compared to Nix Creme Rinse (1% Permethrin) for the Treatment of Head Lice,” Pediatric Dermatology, Vol. 21, No. 6, 2004, pp. 670-674. doi:10.1111/j.0736-8046.2004.21613.x
[12]	K. S. Yoon, J. R. Gao, S. H. Lee, J. M. Clark, L. Brown and D. Taplin, “Permethrin-Resistant Human Head Lice, Pediculus capitis, and Their Treatment,” Archives of Dermatology, Vol. 139, No. 8, 2003, pp. 994-1000. doi:10.1001/archderm.139.8.994
[13]	CDC, “Malathion Frequently Asked Questions,” 2011. http://www.cdc.gov/parasites/lice/head/gen_info/faqs_malathion.html
[14]	C. G. Burkhart and C. N. Burkhart, “Safety and Efficacy of Pediculicides for Head Lice,” Expert Opinion on Drug Safety, Vol. 5, No. 1, 2006, pp. 169-179. doi:10.1517/14740338.5.1.169
[15]	AHRQ, “Guidelines for the Diagnosis and Treatment of Pediculosis capitis (Head Lice) in Children and Adults,” 2011. http://www.guideline.gov/content.aspx?id=12784&search=head+lice+treatment
[16]	H. I. Katz, E. Gross, M. Buxman, S. E. Prawer, E. H. Schwartzel and J. R. Gibson, “A Double-Blind, Vehicle-Controlled Paired Comparison of Halobetasol Propionate Cream on Patients with Plaque Psoriasis,” Journal of the American Academy of Dermatology, Vol. 25, No. 6, 1991, pp. 1175-1178. doi:10.1016/0190-9622(91)70321-R
[17]	K. Vie, A. Pons-Guiraud, P. Dupuy and H. Maibach, “Tolerance Profile of a Sterile Moisturizer and Moisturizing Cleanser in Irritated and Sensitive Skin,” Journal of the American Academy of Dermatology, Vol. 11, No. 3, 2000, pp. 161-164. doi:10.1053/ajcd.2000.7183
[18]	D. Wilson and D. Nix, “Evaluation of a Once-Daily Moisturizer Used to Treat Xerosis in Long-Term Care Patients,” Ostomy Wound Management, Vol. 51, No. 11, 2005, pp. 52-60.
[19]	M. Lebwohl, L. Clark and J. Levitt, “Therapy for Head Lice Based on Life Cycle, Resistance, and Safety Considerations,” Pediatrics, Vol. 119, No. 5, 2007, pp. 965974. doi:10.1542/peds.2006-3087
[20]	S. H. Lee, K.-S. Yoon, M. S. Williamson, S. J. Goodson, M. Takano-Lee, J. D. Edman, et al., “Molecular Analysis of KDR-Like Resistance in Permethrin-Resistant Strains of Head Lice, Pediculus capitis,” Pesticide Biochemistry and Physiology, Vol. 66, No. 2, 2000, pp. 130-143. doi:10.1006/pest.1999.2460
[21]	T. L. Meinking, L. Serrano, B. Hard, P. Entzel, G. Lemard, E. Rivera, et al., “Comparative in Vitro Pediculicidal Efficacy of Treatments in a Resistant Head Lice Population in the United States,” Archives of Dermatology, Vol. 138, No. 2, 2002, pp. 220-224. doi:10.1001/archderm.138.2.220
[22]	S. Fahmy, J. M. Christensen and L. Ma, “In Vitro and In Vivo Evaluation of Pesticidal and Ovicidal Activities of Chemical Pesticides of OTC Products, Home Remedies, Essential Oils and Other factors Associated with Efficacy of Treatment of Head Lice Infestations,” Journal of Pharmaceutical Research and Clinical Practice, Vol. 2, No. 1, 2012, pp. 1-13.
[23]	D. Taplin, T. L. Meinking, P. M. Castillero and R. Sanchez, “Permethrin 1% Creme Rinse for the Treatment of Pediculus humanus var Capitis Infestation,” Pediatric Dermatology, Vol. 3, No. 4, 1986, pp. 344-348. doi:10.1111/j.1525-1470.1986.tb00538.x
[24]	M. Kristensen, “Identification of Sodium Channel Mutations in Human Head Louse (Anoplura: Pediculidae) from Denmark,” Journal of Medical Entomology, Vol. 42, No. 5, 2005, pp. 826-829. doi:10.1603/0022-2585(2005)042[0826:IOSCMI]2.0.CO;2
[25]	M. Kristensen, M. Knorr, A. M. Rasmussen and J. B. Jespersen, “Survey of Permethrin and Malathion Resistance in Human Head Lice Populations from Denmark,” Journal of Medical Entomology, Vol. 43, No. 3, 2006, pp. 533-538. doi:10.1603/0022-2585(2006)43[533:SOPAMR]2.0.CO;2
[26]	J. Huekelbach, D. Pilger, F. A. Oliveria, A. Khakban, L. Ariza and H. Feldmeier, “A Highly Efficacious Pediculicide Based Dimeticone: Randomized Observer Blinded Comparative Trial,” BMC Infectious Diseases, Vol. 8, 2008, pp. 115-124. doi:10.1186/1471-2334-8-115
[27]	I. F. Burgess, “The Mode of Action of Dimeticone 4% Lotion against Head Lice, Pediculus capitus,” BMC Pharmacology, Vol. 9, 2009, pp. 3-11. doi:10.1186/1471-2210-9-3
[28]	J. Huekelbach, A. Asenov, O. Liesenfeld, A. Mirmohammadsadegh and F. A. Oliveria, “A New Two Phase Dimeticone Pediculicide Shows High Efficacy in Comparative Bioassay,” BMC Dermatology, Vol. 9, 2009, pp. 12-18. doi:10.1186/1471-5945-9-12
[29]	I. F. Burgess, P. N. Lee and G. Matlock, “Randomised, Controlled, Assessor Blind Trial Comparing 4% Dimeticone Lotion with 0.5% Malathion Liquid for Head Louse Infestation,” Plos One, Vol. 2, No. 11, 2007, pp. e1127e1134. doi:10.1371/journal.pone.0001127