Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Phase 2
Terminated
- Conditions
- Lice Infestations
- Interventions
- Drug: MALG
- Registration Number
- NCT00291057
- Lead Sponsor
- Taro Pharmaceuticals USA
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MALG MALG
- Primary Outcome Measures
Name Time Method Change in cholinesterase level 1 day
- Secondary Outcome Measures
Name Time Method Clinical evidence of cholinesterase inhibition 1 day Local tolerability 1 day Cure of head lice 14 days after last treatment 2 weeks
Trial Locations
- Locations (1)
Investigator Site
🇺🇸Miamiville, Ohio, United States