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Sponsored by: |
Taro Pharmaceuticals USA |
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Information provided by: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00291057 |
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 |
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Lice Infestations |
Drug: MALG |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis |
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 |
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1: Experimental
MALG
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Drug: MALG
30 minute application
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Ages Eligible for Study: | 6 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Scottsdale, Arizona, United States, 85251 | |
United States, Florida | |
West Palm Beach, Florida, United States, 33409 | |
St. Petersburg, Florida, United States, 33710 | |
United States, New York | |
New York, New York, United States, 10017 | |
United States, Ohio | |
Miamiville, Ohio, United States, 45147 |
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 |
Responsible Party: | Taro Pharmaceuticals USA ( Medical Director ) |
Study ID Numbers: | MALG-0508 |
Study First Received: | February 10, 2006 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00291057 |
Health Authority: | United States: Food and Drug Administration |
Pediculosis Head Lice |
Lice Infestations Skin Diseases, Infectious Skin Diseases Parasitic Diseases Malathion |
Ectoparasitic Infestations Skin Diseases, Parasitic |