NCT00927407

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediculosis

Interventions

Type	Name	Description
DRUG	Malathion gel 0.5%	Malathion gel 0.5% applied to the scalp for 30 minutes
DRUG	Malathion lotion 0.5%	Malathion lotion 0.5% applied to scalp for 12 hours

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-06-25
• Last updated: 2013-12-24

Locations

1 site across 1 country: India