Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice - Full Text View

Sponsor:	Taro Pharmaceuticals USA
Information provided by:	Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:	NCT00244439

Purpose

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Condition	Intervention	Phase
Lice Infestations	Drug: MALG Drug: Ovide (malathion) lotion 0.05% Drug: Permethrin 1%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis

Resource links provided by NLM:

Drug Information available for: Permethrin Malathion

U.S. FDA Resources

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:

Cure of Head Lice [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of treatments [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	360
Study Start Date:	December 2005
Study Completion Date:	December 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MALG	Drug: MALG 30 minute application
2: Active Comparator Ovide	Drug: Ovide (malathion) lotion 0.05% 8-12 hour application
3: Active Comparator Permethrin 1%	Drug: Permethrin 1% 10 minute application

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed active head lice infestation
Patient, parent or guardian must be able to apply the treatment
Entire household must be screened
All infested persons must agree to participate

Exclusion Criteria:

Allergy to pediculicides, hair care products or chrysanthemums
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Female patients who are pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244439

Locations

United States, Arizona

Scottsdale, Arizona, United States
United States, Florida

West Palm Beach, Florida, United States

St. Petersburg, Florida, United States

Miami, Florida, United States
United States, New York

New York, New York, United States
United States, Ohio

Miamiville, Ohio, United States

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

Principal Investigator:	John Goodman, MD	Hill Top Research
Principal Investigator:	Robert E Lewine, MD	Hill Top Research
Principal Investigator:	Wanda M Boote, MD	Hill Top Research
Principal Investigator:	Jan Fu, MD, PhD	Hill Top Research
Principal Investigator:	Terri Meinking	Global Health Associates Miami
Principal Investigator:	Micheal J Alaimo, RPh, DO	Hill Top Research

More Information

No publications provided

Responsible Party:	Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers:	MALG-0506
Study First Received:	October 24, 2005
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00244439 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:

Head Lice
Pediculosis capitis

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on November 05, 2009