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Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00752973
First received: September 15, 2008
Last updated: January 19, 2012
Last verified: January 2012
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
Pediculosis
 Drug: MALG (malathion) Treatment
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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:

MedlinePlus related topics: Lice
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: 2-3 weeks ] [ Designated as safety issue: Yes ]
  • Cure of head lice 14 days after last treatment [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
MALG treatment
 Drug: MALG (malathion) Treatment
MALG applied for 30 minutes
Other Name: Novel malathion formulation

  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

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: NCT00752973

Locations
United States, Arkansas
Children's Investigational Research Program, LLC (CHIRP)
Bentonville, Arkansas, United States, 72712
Harvey Pediatrics, PLLC
Jonesboro, Arkansas, United States, 72401
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
Principal Investigator: Bryan Harvey, MD Harvey Pediatrics, PLLC
  More Information

Publications:

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00752973     History of Changes
Other Study ID Numbers: MALG-0813
Study First Received: September 15, 2008
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
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 May 21, 2013