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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291057
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 13, 2006
Last Update Posted : December 23, 2013
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

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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

Arm Intervention/treatment
Experimental: 1
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00291057

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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
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Responsible Party: Medical Director, Taro Pharmaceuticals USA Identifier: NCT00291057    
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:
Head Lice
Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases