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

Sponsor:	Taro Pharmaceuticals USA
Information provided by:	Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00927407

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:

Drug Information available for: Malathion

U.S. FDA Resources

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
Malathion gel 0.05%: Experimental 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
Malathion lotion 0.5%: Active Comparator Malathion lotion 0.5% treatment for head lice	Drug: Malathion lotion 0.5% Malathion lotion 0.5% applied to scalp for 12 hours

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, Navi Mumbai
Drug Monitoring Research Institute Pvt. Ltd.
Rabale, Navi Mumbai, India, 400701

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

Principal Investigator:

Nilesh Patel, MD

Drug Monitoring Research Institute Pvt. Ltd.

More Information

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 Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11.

Responsible Party:	Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers:	MALG-0603
Study First Received:	June 23, 2009
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00927407 History of Changes
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:

Ectoparasitic Infestations
Neurotransmitter Agents
Skin Diseases, Parasitic
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

Cholinergic Agents
Malathion
Pharmacologic Actions
Lice Infestations
Cholinesterase Inhibitors
Skin Diseases, Infectious
Parasitic Diseases

ClinicalTrials.gov processed this record on February 08, 2010