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Background: Head lice most commonly affect children, ages 3 to 11. Concerns exist about the safety and efficacy of pesticide-based treatments. Published studies suggest dimethicone is a potentially safe and effective non-toxic treatment, but have not evaluated 100 % dimethicone in a pediatric population. The objectives were to evaluate the efficacy and safety of 100 % dimethicone for the treatment of head lice in children, monitored by school nurses. Methods: This was a multi-site, open-label study of a 100 % dimethicone gel for the treatment of head lice in a pediatric population. Children (ages 3-12) suspected of infestation with head lice were evaluated by school nurses at six schools and daycare programs in New York and New Jersey. Inclusion criteria were presence of at least three live lice, or one live louse and 10 viable eggs (eggs found within 1.27 cm of the scalp) and no use of any head lice treatment within four weeks of enrollment. Counts of live lice and viable eggs found in 58 subjects were tracked at baseline (Day 0) and on Day 1, Day 7, and Day 14 after treatment. Results: After 1 day of treatment with 100 % dimethicone, 98.30 % of subjects were free of live lice and 55.20 % were free of viable eggs. On day 14, 96.50 % were still free of live lice, and 80.70 % were free of viable eggs. All subjects were monitored by the school nurse at baseline and throughout the study period for adverse effects, including scalp erythema, excoriation, flaking and edema. There was one adverse event of skin irritation lasting 10 min, and no serious adverse events reported. Overall, scalp conditions improved from the baseline: 10 subjects (17.5 %) reported mild to moderate scalp erythema on day 1, compared with only one subject (1.7 %) on day 14; 8 subjects (14.3 %) reported mild scalp excoriation on day 1, with none reporting on day 14. Conclusions: 100 % dimethicone was found to be a safe and highly effective treatment for pediatric head lice. Because dimethicone avoids pesticide exposure and resistance issues, dimethicone should be considered as a first-line treatment for head lice. [ABSTRACT FROM AUTHOR]