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

Tracking Information

First Received Date ^ICMJE

October 24, 2005

Last Updated Date

May 4, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cure of Head Lice

Change History

Complete list of historical versions of study NCT00244439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Lice Infestations

Intervention ^ICMJE

Drug: MALG
Drug: Ovide (malathion) lotion 0.05%
Drug: Permethrin 1%

Study Arms / Comparison Groups

Experimental: MALG
Active Comparator: Ovide
Active Comparator: Permethrin 1%

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

360

Completion Date

December 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00244439

Responsible Party

Medical Director, Taro Pharmaceuticals USA

Study ID Numbers ^ICMJE

MALG-0506

Study Sponsor ^ICMJE

Taro Pharmaceuticals USA

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Taro Pharmaceuticals USA

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP