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

No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).

Time frame: Day 7±1 and Day 14 or Day 21

Population: No statistical analysis provided for Clinical Cure

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

Population: 10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.~subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts.

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)

Population: 11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.

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.

Time frame: at 1 hr (Day 0)

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 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 participants had wheezing as medical history which continued without increase in severity throughout the treatment.

Time frame: at 24 hrs (Day 1)

To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.

Time frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)

Population: A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).