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

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.