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

December 19, 2013 updated by: Taro Pharmaceuticals USA

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States
        • Investigator site
    • Florida
      • St. Petersburg, Florida, United States
        • Investigator site
      • West Palm Beach, Florida, United States
        • Investigator site
    • New York
      • New York, New York, United States
        • Investigator site
    • Ohio
      • Miamiville, Ohio, United States
        • Investigator site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MALG
30 minute application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cholinesterase level
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical evidence of cholinesterase inhibition
Time Frame: 1 day
1 day
Local tolerability
Time Frame: 1 day
1 day
Cure of head lice 14 days after last treatment
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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