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

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%.

Study Overview

• Status: Completed
• Conditions: Pediculosis
• Intervention / Treatment: Drug: Malathion gel 0.5%; Drug: Malathion 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Navi Mumbai
    • Rabale, Navi Mumbai, India
      • Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Publications and helpful links

General Publications

• Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 23, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 21, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Head Lice
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Malathion
• Other Study ID Numbers: MALG-0603