Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice

Study Overview
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Brief Summary
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In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.

Detailed Description
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A randomized, single-dose, parallel group, comparative PK study. Patients will be randomly assigned in 1:1 ratio to the study products. Twenty four (24) consenting patients, age 18 years and older, who meet Inclusion/Exclusion criteria will be enrolled in this study. 12 Patients will be treated with Malathion Gel, 0.5% and other 12 Patients will be treated with Ovide Lotion 0.5%. The study will be single centre and conducted only in India. The primary objective of this study is to compare the systemic exposure of Malathion 0.5% Gel manufactured by Taro Pharmaceuticals USA, Inc. to that of the OVIDE Lotion 0.5%, currently marketed by Taro Pharmaceutical USA, Inc., in adult Patients with head lice. The secondary objective is to determine the link between the exposure and cholinesterase activity.

Official Title
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A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (Malathion) Lotion 0.5% in Patients With Pediculosis Capitis

Conditions
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Pediculosis

Intervention / Treatment
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* Drug: Malathion gel 0.5%
* Drug: Malathion lotion 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female Patients 18 years of age or older and healthy presenting with Pediculosis capitis The Patient must be willing to consent to the Patient's treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration. Exclusion Criteria: Individuals with history of irritation or sensitivity to pediculicides or hair care products Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or Sponsor, will interfere with the evaluation. Individuals previously treated with a pediculicide within 4 weeks of the study. Individuals who exhibit potential signs and symptoms of cholinesterase inhibition. Patients currently receiving sulfonamide antibiotics or ivermectin.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Malathion gel 0.05%<br>Malathion gel 0.5% topical treatment for head lice | Drug: Malathion gel 0.5%<br>* Malathion gel 0.5% applied to the scalp for 30 minutes<br>* Other names: MALG;|
| Active Comparator: Malathion lotion 0.5%<br>Malathion lotion 0.5% treatment for head lice | Drug: Malathion lotion 0.5%<br>* Malathion lotion 0.5% applied to scalp for 12 hours<br>* Other names: OVIDE lotion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of blood and urinary levels of malathion and metabolites |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure cholinesterase levels and compare to malathion metabolite levels |  | 48 hours | 

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