Abstract
The present clinical trial was conducted to obtain additional data for the safety and efficacy of a head lice shampoo that is free of silicone compared with an anti-head lice product containing dimethicone. Both products act by a physical mode of action. This randomized, investigator-blinded, controlled clinical study was conducted between July and November 2016 in households of two villages (Abou Rawash and Shandalat) in Egypt. Children older than 2 years with an active head lice infestation were treated with either a shampoo-based head lice treatment containing neem extract (Licener®) or dimethicone (Jacutin® Pedicul Fluid) on day 1 and additionally on day 9. Assessment for living lice by combing was conducted before and 1–2 h after treatment and on days 5 and 13. The main objective was to demonstrate a cure rate of the test product of at least 85% after a single application (day 5 and 9). Secondary objectives were to scrutinize patient safety and satisfaction as well as cure rates on day 13 after two treatments and the evaluation of ovicidal and licicidal efficacies of the products. Sixty-one children in the test-group (Licener®) and 58 children in the reference group (Jacutin® Pedicul Fluid) were included in this study. The test product and the reference product were very well tolerated. Both products exceeded the objective of cure rates of over 85% after single treatment (test group 60/60 = 100%; 95% CI = 94.04–100.00%; reference group 54/57 = 94.74%; 95% CI = 85.38–98.90%; p = 0.112; CI by Clopper-Pearson) and after two treatments (test group 58/58 = 100%; 95% CI = 93.84–100.00%; reference group 52/54 = 96.30%; 95% CI = 87.25–99.55%; p = 0.230) with higher cure rates and non-inferiority for the test product. The combined success rate shows significant superiority of the test product against the reference product (test group 58/58 = 100%; 95% CI = 93.84–100.00%; reference group 49/54 = 90.7%; 95% CI = 79.70–96.92%; p = 0.024). The test product showed higher ovicidal efficacy than the reference product. Thus, the present study demonstrates that a single treatment with a head lice product like Licener® can be sufficient to eliminate a head lice infestation.
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References
Abdel-Ghaffar F, Abdel-Aty M, Rizk I, Al-Quraishy S, Semmler M, Gestmann F, Hoff NP (2016) Head lice in progress: what could/should be done-a report on an in vivo and in vitro field study. Parasitol Res 115:4245–4249
Abdel-Ghaffar F, Al-Quraishy S, Al-Rasheid KA, Mehlhorn H (2012) Efficacy of a single treatment of head lice with a neem seed extract: an in vivo and in vitro study on nits and motile stages. Parasitol Res 110:277–280
Abdel-Ghaffar F, Semmler M (2007) Efficacy of neem seed extract shampoo on head lice of naturally infected humans in Egypt. Parasitol Res 100:329–332
Abdel-Ghaffar F, Semmler M, Al-Rasheid K, Klimpel S, Mehlhorn H (2010) Comparative in vitro tests on the efficacy and safety of 13 anti-head-lice products. Parasitol Res 106:423–429
Badiaga S, Brouqui P (2012) Human louse-transmitted infectious diseases. Clin Microbiol Infect 18:332–337
Barker SC, Burgess I, Meinking TL, Mumcuoglu KY (2012) International guidelines for clinical trials with pediculicides. Int J Dermatol 51:853–858
Burgess IF, Brown CM, Burgess NA, Kaufman J (2014) Can head louse repellents really work? Field studies of piperonal 2% spray. PeerJ 2:e351
Burgess IF, Burgess NA, Brunton ER (2013) Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse. BMC Pharmacol Toxicol 14:43. doi:10.1186/2050-6511-1114-1143
Burgess IF, Lee PN, Kay K, Jones R, Brunton ER (2012) 1,2-Octanediol, a novel surfactant, for treating head louse infestation: identification of activity, formulation, and randomised, controlled trials. PLoS One 7:e35419
Burgess IF, Lee PN, Matlock G (2007) Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One 2:e1127
Do-Pham G, Le Cleach L, Giraudeau B, Maruani A, Chosidow O, Ravaud P (2014) Designing randomized-controlled trials to improve head-louse treatment: systematic review using a vignette-based method. J Invest Dermatol 134:628–634
Dorge DD, Kuhn T, Klimpel S (2017) Flammability testing of 22 conventional European pediculicides. Parasitol Res 116:1189–1196
Downs AM, Stafford KA, Harvey I, Coles GC (1999) Evidence for double resistance to permethrin and malathion in head lice. Br J Dermatol 141:508–511
Gallardo A, Mougabure-Cueto G, Vassena C, Picollo MI, Toloza AC (2012) Comparative efficacy of new commercial pediculicides against adults and eggs of Pediculus humanus capitis (head lice). Parasitol Res 110:1601–1606
Gallardo A, Toloza A, Vassena C, Picollo MI, Mougabure-Cueto G (2013) Comparative efficacy of commercial combs in removing head lice (Pediculus humanus capitis) (Phthiraptera: Pediculidae). Parasitol Res 112:1363–1366
Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH (2006) An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics 118:1962–1970
Heukelbach J, Pilger D, Oliveira FA, Khakban A, Ariza L, Feldmeier H (2008) A highly efficacious pediculicide based on dimeticone: randomized observer blinded comparative trial. BMC Infect Dis 8:115. doi:10.1186/1471-2334-1188-1115
Hill N, Moor G, Cameron MM, Butlin A, Preston S, Williamson MS, Bass C (2005) Single blind, randomised, comparative study of the bug buster kit and over the counter pediculicide treatments against head lice in the United Kingdom. BMJ 331:384–387
Ihde ES, Boscamp JR, Loh JM, Rosen L (2015) Safety and efficacy of a 100% dimethicone pediculocide in school-age children. BMC Pediatr 15:70
Kurt O, Balcioglu IC, Limoncu ME, Girginkardesler N, Arserim SK, Gorgun S, Oyur T, Karakus M, Duzyol D, Gokmen AA, Kitapcioglu G, Ozbel Y (2015) Treatment of head lice (Pediculus humanus capitis) infestation: is regular combing alone with a special detection comb effective at all levels? Parasitol Res 114:1347–1353
Lebwohl M, Clark L, Levitt J (2007) Therapy for head lice based on life cycle, resistance, and safety considerations. Pediatrics 119:965–974
Mehlhorn H (2012) Head lice and their control: a never ending story. In: Preedy VR (ed) Handbook of hair in health and disease. Wageningen Academic Publishers, Wageningen, pp 355–386
Moshki M, Zamani-Alavijeh F, Mojadam M (2017) Efficacy of peer education for adopting preventive behaviors against head lice infestation in female elementary school students: a randomised controlled trial. PLoS One 12:e0169361
Mumcuoglu KY, Klaus S, Kafka D, Teiler M, Miller J (1991) Clinical observations related to head lice infestation. J Am Acad Dermatol 25:248–251
Raoult D, Dutour O, Houhamdi L, Jankauskas R, Fournier PE, Ardagna Y, Drancourt M, Signoli M, La VD, Macia Y, Aboudharam G (2006) Evidence for louse-transmitted diseases in soldiers of Napoleon’s grand Army in Vilnius. J Infect Dis 193:112–120
Semmler M, Abdel-Ghaffar F, Al-Quraishy S, Al-Rasheid KA, Mehlhorn H (2012) Why is it crucial to test anti-lice repellents? Parasitol Res 110:273–276
Strycharz JP, Lao AR, Alves AM, Clark JM (2012) Ovicidal response of NYDA formulations on the human head louse (Anoplura: Pediculidae) using a hair tuft bioassay. J Med Entomol 49:336–342
Wolf L, Eertmans F, Wolf D, Rossel B, Adriaens E (2016) Efficacy and safety of a mineral oil-based head lice shampoo: a randomized, controlled, investigator-blinded, comparative study. PLoS One 11:e0156853
Yang YC, Lee SH, Clark JM, Ahn YJ (2009) Ovicidal and adulticidal activities of Origanum majorana essential oil constituents against insecticide-susceptible and pyrethroid/malathion-resistant Pediculus humanus capitis (Anoplura: Pediculidae). J Agric Food Chem 57:2282–2287
Acknowledgements
We thank Hennig Arzneimittel GmbH & Co. KG, Flörsheim, Germany, for providing the sufficient bottles of Licener® to carry out the test and Alpha-Biocare GmbH, Neuss, Germany, for sponsoring this study.
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F. Gestmann is an employee of the sponsor (Alpha-Biocare GmbH, Neuss, Germany). M. Semmler, F. Abdel-Ghaffar, M. Abdel-Aty, I. Rizk, S. Al-Quraishy and N.P. Hoff took part in the study design and implementation of at least one previous study with the test product. The other authors have declared that they have no conflict of interest regarding the content of this article.
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The study was conducted under local institutional review and in accordance with the Declaration of Helsinki (last revision in October, 2013 by the 64th General Assembly in Fortaleza, Brazil) and the European standard DIN EN ISO 14155:2012-01 (Clinical investigation of medical devices for human subjects—Good clinical practice) and the GCP Regulation. This is a study of CE-marked medical devices, which were not modified and not used outside their CE mark intended purpose and does therefore not require ethic approval which is also applicable for studies in Egypt.
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Semmler, M., Abdel-Ghaffar, F., Gestmann, F. et al. Randomized, investigator-blinded, controlled clinical study with lice shampoo (Licener®) versus dimethicone (Jacutin® Pedicul Fluid) for the treatment of infestations with head lice. Parasitol Res 116, 1863–1870 (2017). https://doi.org/10.1007/s00436-017-5461-7
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DOI: https://doi.org/10.1007/s00436-017-5461-7