Clinical Trial: Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Study Status: Terminated
Recruit Status: Terminated
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: Change in cholinesterase level [ Time Frame: 1 day ]
Original Primary Outcome: Change in cholinesterase level
Current Secondary Outcome:
- Clinical evidence of cholinesterase inhibition [ Time Frame: 1 day ]
- Local tolerability [ Time Frame: 1 day ]
- Cure of head lice 14 days after last treatment [ Time Frame: 2 weeks ]
Original Secondary Outcome:
- Clinical evidence of cholinesterase inhibition
- Local tolerability
- Cure of head lice 14 days after last treatment
Information By: Taro Pharmaceuticals USA
Dates:
Date Received: February 10, 2006
Date Started: February 2006
Date Completion:
Last Updated: December 19, 2013
Last Verified: November 2013
