Phase 3
Completed N=12
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Pediculosis
Source: ClinicalTrials.gov NCT00752973 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). — -1.8; -0.5 percentage change in cholinesterase
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). |
-1.8; -0.5 | — |
| PRIMARY Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). |
-1.7; 1.4 | — |
| PRIMARY Participants With the Clinical Evidence of Cholinesterase Inhibition |
— | — |
| PRIMARY Participants Clinically Cured of Head Lice 14 Days After Last Treatment |
12 | — |
| SECONDARY Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. |
11; 1; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed active head lice infestation
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
Data sourced from ClinicalTrials.gov (NCT00752973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.