Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice - Tabular View

Tracking Information

First Received Date ^ICMJE

February 10, 2006

Last Updated Date

May 4, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change in cholinesterase level [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Change in cholinesterase level

Change History

Complete list of historical versions of study NCT00291057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical evidence of cholinesterase inhibition [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Local tolerability [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Cure of head lice 14 days after last treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Clinical evidence of cholinesterase inhibition
Local tolerability
Cure of head lice 14 days after last treatment

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Official Title ^ICMJE

Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Brief Summary

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Lice Infestations

Intervention ^ICMJE

Drug: MALG

Study Arms / Comparison Groups

Experimental: MALG

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

Terminated

Estimated Enrollment ^ICMJE

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
Parent or guardian must be able to apply treatment

Exclusion Criteria:

Allergy to pediculicides or hair care products
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Current antibiotic treatment

Gender

Both

Ages

6 Months to 24 Months

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

NCT00291057

Responsible Party

Medical Director, Taro Pharmaceuticals USA

Study ID Numbers ^ICMJE

MALG-0508

Study Sponsor ^ICMJE

Taro Pharmaceuticals USA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	John Goodman, MD	Hill Top Research
Principal Investigator:	Robert A Lewine, MD	Hill Top Research
Principal Investigator:	Michael Brown, MD	Hill Top Research
Principal Investigator:	Jan Fu, MD, PhD	Hill Top Research
Principal Investigator:	Michael J Alaimo, R.Ph., D.O.	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