In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).
Timeframe: Change from Baseline to 1 hour
Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).
Timeframe: Change from baseline to 24 hrs (1 day)
Participants With the Clinical Evidence of Cholinesterase Inhibition
Timeframe: at Baseline
Participants With the Clinical Evidence of Cholinesterase Inhibition
Timeframe: at 1 hr (Day 0)
Participants With the Clinical Evidence of Cholinesterase Inhibition
Timeframe: at 24 hrs (Day 1)
Participants Clinically Cured of Head Lice 14 Days After Last Treatment
Timeframe: Day 7±1 and Day 14 or Day 21