Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Information source: Taro Pharmaceuticals USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lice Infestations
Intervention: MALG (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Taro Pharmaceuticals USA Official(s) and/or principal investigator(s):
John Goodman, MD, Principal Investigator, Affiliation: Hill Top Research
Robert A Lewine, MD, Principal Investigator, Affiliation: Hill Top Research
Michael Brown, MD, Principal Investigator, Affiliation: Hill Top Research
Jan Fu, MD, PhD, Principal Investigator, Affiliation: Hill Top Research
Michael J Alaimo, R.Ph., D.O., Principal Investigator, Affiliation: Hill Top Research
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.
Clinical Details
Official title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Change in cholinesterase level
Secondary outcome: Clinical evidence of cholinesterase inhibitionLocal tolerability Cure of head lice 14 days after last treatment
Eligibility
Minimum age: 6 Months.
Maximum age: 24 Months.
Gender(s): Both.
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
Locations and Contacts
Scottsdale, Arizona 85251, United States
West Palm Beach, Florida 33409, United States
St. Petersburg, Florida 33710, United States
New York, New York 10017, United States
Miamiville, Ohio 45147, United States
Additional Information
Starting date: February 2006
Ending date: December 2006
Last updated: April 3, 2008
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