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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00927407
First received: June 23, 2009
Last updated: December 21, 2013
Last verified: December 2013
  Purpose

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%.


Condition Intervention Phase
Pediculosis
Drug: Malathion gel 0.5%
Drug: Malathion lotion 0.5%
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Measurement of blood and urinary levels of malathion and metabolites [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure cholinesterase levels and compare to malathion metabolite levels [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: July 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: OVIDE lotion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927407

Locations
India
Investigator Site
Rabale, Navi Mumbai, India
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

Publications:
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00927407     History of Changes
Other Study ID Numbers: MALG-0603
Study First Received: June 23, 2009
Last Updated: December 21, 2013
Health Authority: India: Drugs Controller General of India
United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Malathion
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014