Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Malathion

Criteria

Inclusion Criteria:

• Confirmed active head lice infestation

• Parent or guardian must be able to apply treatment

Exclusion Criteria:

• Allergy to pediculicides or hair care products

• Scalp conditions other than head lice

• Previous head lice treatment within the past 4 weeks

• Current antibiotic treatment