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Last Updated: February 17, 2020

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CLINICAL TRIALS PROFILE FOR MALATHION

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505(b)(2) Clinical Trials for Malathion

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00244439 Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice Completed Taro Pharmaceuticals USA Phase 3 2005-12-01 Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
New Formulation NCT00927472 Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Completed Taro Pharmaceuticals USA Phase 3 2009-08-01 In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
New Formulation NCT00963508 Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Completed Taro Pharmaceuticals USA Phase 3 2009-08-01 In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Malathion

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00244439 Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice Completed Taro Pharmaceuticals USA Phase 3 2005-12-01 Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
NCT00291057 Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice Terminated Taro Pharmaceuticals USA Phase 2 2006-02-01 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.
NCT00752973 Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice Completed Taro Pharmaceuticals USA Phase 2/Phase 3 2008-09-01 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.
NCT00819520 Ivermectin in the Treatment of Head Lice Completed Johnson & Johnson Consumer and Personal Products Worldwide Phase 3 2004-02-01 The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.
NCT00927407 Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Completed Taro Pharmaceuticals USA Phase 1 2009-07-01 In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Malathion

Condition Name

Condition Name for Malathion
Intervention Trials
Pediculosis 4
Lice Infestations 3
Head Lice 1
Scabies 1
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Condition MeSH

Condition MeSH for Malathion
Intervention Trials
Lice Infestations 8
Parasitic Diseases 3
Scabies 1
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Clinical Trial Locations for Malathion

Trials by Country

Trials by Country for Malathion
Location Trials
United States 15
Israel 1
France 1
Ireland 1
Solomon Islands 1
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Trials by US State

Trials by US State for Malathion
Location Trials
Arkansas 3
Florida 3
Ohio 2
New York 2
Arizona 2
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Clinical Trial Progress for Malathion

Clinical Trial Phase

Clinical Trial Phase for Malathion
Clinical Trial Phase Trials
Phase 3 5
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Malathion
Clinical Trial Phase Trials
Completed 6
Active, not recruiting 1
Terminated 1
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Clinical Trial Sponsors for Malathion

Sponsor Name

Sponsor Name for Malathion
Sponsor Trials
Taro Pharmaceuticals USA 6
London School of Hygiene and Tropical Medicine 1
Johnson & Johnson Consumer and Personal Products Worldwide 1
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Sponsor Type

Sponsor Type for Malathion
Sponsor Trials
Industry 7
Other 1
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Serving leading biopharmaceutical companies globally:

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