Clinical Trial: Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Brief Summary:
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.
Detailed Summary:
Sponsor: Taro Pharmaceuticals USA
Current Primary Outcome:
- Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). [ Time Frame: Change from Baseline to 1 hour ]
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.
- Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). [ Time Frame: Change from baseline to 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)/ Basel
Original Primary Outcome: Change in Cholinesterase Level [ Time Frame: 1 day ]
Current Secondary Outcome: Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. [ Time Frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) ]
To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.
Original Secondary Outcome:
- Clinical Evidence of Cholinesterase Inhibition [ Time Frame: 1 day ]
- Local Tolerability [ Time Frame: 2-3 weeks ]
- Cure of Head Lice 14 Days After Last Treatment [ Time Frame: 2-3 weeks ]
Information By: Taro Pharmaceuticals USA
Dates:
Date Received: September 15, 2008
Date Started: September 2008
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014