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

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.

Head Lice at School: Traditional Medicine and Community Engagement

“…Or it may indicate that the ovicidal effectiveness of the solution is higher than previously observed in vitro. 18 Although this is still a modest success rate, 55.2% in comparison with formulations containing chemical pesticides such as benzyl alcohol, which had a 75% success rate in an open-label phase II trial, 21 or a formula containing sodium chloride 1%, which saw an 85% success rate without combing, 19 or even bug busting performed by nurses in a controlled situation, 7,20 we point out that we observed no safety concerns in the population tested. In addition, the building of resistance to the product is unlikely in the future with this formulation and the use of an appropriate nit comb could come in handy as a complement to the product's application since it facilitates the removal of adult head lice.…”

“…Those individuals were included in the analysis, although they had not been examined by trained staff before and after treatment to keep them from being embarrassed. Among the participants with head lice nits and/or adults (67 out of 280), the number of participants with nits and adults dropped from 70.2% (N = 47) to 19.4% (N = 13), and 55.2% (N = 37) of the participants who had pediculosis before treatment showed no signs of nits or adult lice after treatment. The number of participants showing only nits before treatment dropped from 19.4% to 12% after treatment.…”

“…Desiccation is the suggested mode of action. 18,19 A study of a whole-school approach conducted in the United Kingdom, Belgium, and Denmark shows that using a cost-effective treatment such as wet combingwhich consists of using a conditioner and the systematic use of a comb (with teeth < 0.3 mm apart) in a coordinated community program to eradicate head lice-is efficient regardless of social inequalities. 7 In a pilot trial, a 53% success rate at first use and total eradication in all families assigned the treatment were achieved by day 24 after using a wet-combing method.…”

“…Desiccation is the suggested mode of action. 18 , 19 …”

Treatment of Head Louse Infestation with a Novel Mixture Made of Semi-Crystalline Polymers and Plant Extracts: Blind, Randomized, Controlled, Superiority Trial

“…For sample size determination, we anticipated that there was likely to be a disparity in efficacy between the new semi-crystalline lotion and Permethrin 1% lotion, based on previous data (in vitro studies for the experimental product and data available in the literature for permethrin). For a randomize-by-individual approach, a sample size of 17 per group was estimated to have at least 80% power with a type I error rate (one-sided) of 2.5% to detect a difference of 38% between the success rates for the experimental lotion and 1% Permethrin, based on a 98% success rate for the experimental lotion (in vitro test) and evidence suggesting lower success rates with 1% Permethrin (mean of 62.5% according to available data) [33][34][35][36][37][38][39][40][41][42][43].…”