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

Phase 1

Completed

• Conditions: Pediculosis
• Interventions: Drug: Malathion gel 0.5%; Drug: Malathion lotion 0.5%

• Registration Number: NCT00927407
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-25
• Study Start: 2009-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-21
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Malathion gel 0.05%	Malathion gel 0.5%	Malathion gel 0.5% topical treatment for head lice
Malathion lotion 0.5%	Malathion lotion 0.5%	Malathion lotion 0.5% treatment for head lice

Primary Outcome Measures

Name	Time	Method
Measurement of blood and urinary levels of malathion and metabolites	48 hours

Secondary Outcome Measures

Name	Time	Method
Measure cholinesterase levels and compare to malathion metabolite levels	48 hours

Trial Locations

Locations (1)

Investigator Site; 🇮🇳 Rabale, Navi Mumbai, India