At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
MALG (malathion) Treatmentdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
In Brief
A Phase 3 clinical trial evaluating MALG (malathion) Treatment for Pediculosis. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediculosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionDec 2011
Study CompletionJan 2012
TodayJul 2026
First PostedSep 16, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.8 years ago
Interventions
MALG (malathion) Treatmentdrug
MALG applied for 30 minutes