Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).

Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100.

Time frame: Change from Baseline to 1 hour

Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).

Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100.

Time frame: Change from baseline to 24 hrs (1 day)

Participants With the Clinical Evidence of Cholinesterase Inhibition

Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition. 1. Abnormal heart rate. 2. Diarrhea or abdominal cramps. 3. Inappropriate sweating. 4. Pupillary miosis (constriction). 5. Respiratory difficulty such as chest tightness or wheezing. One participant had wheezing as medical history which continued without increase in severity throughout the treatment.

Time frame: at Baseline

Participants With the Clinical Evidence of Cholinesterase Inhibition

Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition : 1. Abnormal heart rate. 2. Diarrhea or abdominal cramps. 3. Inappropriate sweating. 4. Pupillary miosis (constriction). 5. Respiratory difficulty such as chest tightness or wheezing. One participants had wheezing as medical history which continued without increase in severity throughout the treatment.