| Abstract: | Background Ivermectin is a broad‐spectrum parasiticide in widespread systemic use, including as an off‐label treatment for head lice infestation. The potential of the topical use of ivermectin as a treatment for head lice infestation was suggested by an in vitro report of a novel lotion formulation. Objectives This study investigated the relative effectiveness of three ivermectin lotion concentrations (0.15, 0.25, and 0.5%) compared with vehicle placebo in eliminating head lice infestation. Methods In this randomized, blinded study, 78 head lice‐infested subjects, aged 2–62 years, received a single, 10‐minute application of product on day 1. Evaluations were completed at two and six hours post‐application, and on days 2, 8 (±1), and 15 (+2). Safety was assessed according to the evaluations of trained observers and adverse event (AE) reports. Efficacy was assessed according to scalp and hair examinations. Results Compared with placebo, all ivermectin concentrations resulted in the statistically significant (P ≤ 0.003) eradication of head lice through to day 15, with the highest level of eradication (73.7%) in subjects who received the 0.5% concentration. The severity of pruritus decreased from baseline in all treatment groups, including the placebo group, from six hours post‐treatment to day 15, with the greatest reduction in the 0.5% concentration group. No ocular irritation was observed. All three ivermectin treatment strengths and vehicle were well tolerated. Conclusions A single application of a 0.5% concentration of this ivermectin lotion formulation shows promise as a safe and effective treatment for head lice infestation and the associated signs of pruritus. |
