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

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ClinicalTrials.gov Identifier: NCT00291057
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 13, 2006
Last Update Posted : December 23, 2013
Sponsor:
Information provided by:
Taro Pharmaceuticals USA

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.


Condition or disease Intervention/treatment Phase
Lice Infestations Drug: MALG Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lice
Drug Information available for: Malathion
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
MALG
Drug: MALG
30 minute application



Primary Outcome Measures :
  1. Change in cholinesterase level [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Clinical evidence of cholinesterase inhibition [ Time Frame: 1 day ]
  2. Local tolerability [ Time Frame: 1 day ]
  3. Cure of head lice 14 days after last treatment [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291057


Locations
United States, Arizona
Investigator Site
Scottsdale, Arizona, United States
United States, Florida
Investigator Site
St. Petersburg, Florida, United States
Investigator Site
West Palm Beach, Florida, United States
United States, New York
Investigator Site
New York, New York, United States
United States, Ohio
Investigator Site
Miamiville, Ohio, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA

Responsible Party: Medical Director, Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00291057     History of Changes
Other Study ID Numbers: MALG-0508
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: November 2013

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
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs