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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00291057
First received: February 10, 2006
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Lice Infestations
 Drug: MALG
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers 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:
  • Change in cholinesterase level [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: February 2006
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MALG
 Drug: MALG
30 minute application

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291057

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, Florida
St. Petersburg, Florida, United States, 33710
West Palm Beach, Florida, United States, 33409
United States, New York
New York, New York, United States, 10017
United States, Ohio
Miamiville, Ohio, United States, 45147
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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
  More Information

No publications provided

Responsible Party: Medical Director, Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00291057     History of Changes
Other Study ID Numbers: MALG-0508
Study First Received: February 10, 2006
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Pediculosis
Head Lice

Additional relevant MeSH terms:
Parasitic Diseases
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Malathion
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013