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