Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

Study Overview
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Brief Summary
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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.

Official Title
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Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Conditions
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Pediculosis

Intervention / Treatment
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* Drug: MALG (malathion) Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>MALG treatment | Drug: MALG (malathion) Treatment<br>* MALG applied for 30 minutes<br>* Other names: Novel malathion formulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). | Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100. | Change from Baseline to 1 hour | 
| Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). | Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals. Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment. Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100. | Change from baseline to 24 hrs (1 day) | 
| Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition. Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). Respiratory difficulty such as chest tightness or wheezing. One participant had wheezing as medical history which continued without increase in severity throughout the treatment. | at Baseline | 
| Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). Respiratory difficulty such as chest tightness or wheezing. One participants had wheezing as medical history which continued without increase in severity throughout the treatment. | at 1 hr (Day 0) | 
| Participants With the Clinical Evidence of Cholinesterase Inhibition | Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition : Abnormal heart rate. Diarrhea or abdominal cramps. Inappropriate sweating. Pupillary miosis (constriction). Respiratory difficulty such as chest tightness or wheezing. One participants had wheezing as medical history which continued without increase in severity throughout the treatment. | at 24 hrs (Day 1) | 
| Participants Clinically Cured of Head Lice 14 Days After Last Treatment | No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects). | Day 7±1 and Day 14 or Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. | To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation. | Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head Lice